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A Study Comparing Insulin Intensification Therapies in Patients With Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01175811
Recruitment Status : Completed
First Posted : August 5, 2010
Results First Posted : December 18, 2013
Last Update Posted : December 18, 2013
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: Insulin Lispro Premix
Drug: Insulin Glargine
Drug: Insulin Lispro
Enrollment 402
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Premixed Insulin Basal-Bolus
Hide Arm/Group Description

Twice daily (breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (dinner) insulin lispro mix 25 (LM25)

Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks

Once daily (bedtime) insulin glargine and three pre-meal insulin lispro

Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks

Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks

Period Title: Overall Study
Started 199 203
Received at Least 1 Dose of Study Drug 197 202
Completed 183 189
Not Completed 16 14
Reason Not Completed
Adverse Event             1             1
Entry criteria not met             3             1
Lack of Efficacy             1             0
Lost to Follow-up             3             2
Physician Decision             1             1
Protocol Violation             1             2
Withdrawal by Subject             6             7
Arm/Group Title Premixed Insulin Basal-Bolus Total
Hide Arm/Group Description

Twice daily (breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (dinner) insulin lispro mix 25 (LM25)

Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks

Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks

Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks

Total of all reporting groups
Overall Number of Baseline Participants 199 203 402
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 199 participants 203 participants 402 participants
59.0  (9.29) 58.1  (9.05) 58.6  (9.17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 199 participants 203 participants 402 participants
Female
103
  51.8%
93
  45.8%
196
  48.8%
Male
96
  48.2%
110
  54.2%
206
  51.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 199 participants 203 participants 402 participants
Asian 199 203 402
Non-Asian 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 199 participants 203 participants 402 participants
Taiwan 18 20 38
China 157 158 315
Korea, Republic of 24 25 49
1.Primary Outcome
Title Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint
Hide Description Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug and had at least 1 post-baseline evaluable HbA1c data.
Arm/Group Title Premixed Insulin Basal-Bolus
Hide Arm/Group Description:

Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)

Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks

Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks

Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks

Overall Number of Participants Analyzed 197 202
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent HbA1c
-1.05
(-1.19 to -0.92)
-1.06
(-1.19 to -0.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premixed Insulin, Basal-Bolus
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LSmean difference
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.14 to 0.16
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in HbA1c From Baseline to 12 Week Endpoint
Hide Description Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug and who had a baseline and at least 1 post-baseline evaluable HbA1c data.
Arm/Group Title Premixed Insulin Basal-Bolus
Hide Arm/Group Description:

Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)

Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks

Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks

Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks

Overall Number of Participants Analyzed 197 202
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent HbA1c
-0.96
(-1.10 to -0.82)
-0.96
(-1.10 to -0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premixed Insulin, Basal-Bolus
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LSmean Difference
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.15 to 0.16
Estimation Comments [Not Specified]
3.Secondary Outcome
Title The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks
Hide Description The Percentage of participants achieving a haemoglobin A1c (HbA1c) less than or equal (<=) to 6.5% or 7% is defined as 100 multiplied by the number of participants with a HbA1c of the cut-off value (6% or 7%) divided by the number of participants exposed to study drug. Participants with missing HbA1c values at endpoint were treated as not achieving the HbA1c goal.
Time Frame 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study.
Arm/Group Title Premixed Insulin Basal-Bolus
Hide Arm/Group Description:

Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)

Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks

Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks

Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks

Overall Number of Participants Analyzed 197 202
Measure Type: Number
Unit of Measure: Percentage of participants
<=6.5 Percent HbA1c at 12 weeks 6.1 8.9
<=7.0 Percent HbA1c at 12 weeks 26.4 27.7
<=6.5 Percent HbA1c at 24 weeks 9.1 11.9
<=7.0 Percent HbA1c at 24 weeks 29.9 34.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premixed Insulin, Basal-Bolus
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.344
Comments P-value is for the comparison of participants achieving <=6.5% HbA1c at 12 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Premixed Insulin, Basal-Bolus
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.822
Comments P-value is for the comparison of participants achieving <=7.0% HbA1c at 12 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Premixed Insulin, Basal-Bolus
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.417
Comments P-value is for the comparison of participants achieving <=6.5% HbA1c at 24 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Premixed Insulin, Basal-Bolus
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.392
Comments P-value is for the comparison of participants achieving <=7.0% HbA1c at 24 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
Hide Description 7-point Self-monitored Blood Glucose (SMBG) Profiles are measures of blood glucose taken 7 times a day at the morning pre-meal, morning 2-hours post-meal, midday pre-meal, midday 2-hours post-meal, evening pre-meal, evening 2-hours post-meal, and 0300 hour [3 am]. Each participant took measures on 3 non-consecutive days and the average was calculated for each of the 7 time points. The mean of the 7-point averages was calculated for all the participants at baseline, Weeks 12 and 24.
Time Frame Baseline, 12 weeks, and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug
Arm/Group Title Premixed Insulin Basal-Bolus
Hide Arm/Group Description:

Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)

Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks

Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks

Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks

Overall Number of Participants Analyzed 197 202
Mean (Standard Deviation)
Unit of Measure: milligrams per deciliter (mg/dL)
Morning Pre-meal (Week 0) (n=195, 201) 155.0  (34.89) 157.7  (38.81)
Morning Pre-meal (Week 12) (n=187, 191) 141.8  (30.78) 136.5  (31.44)
Morning Pre-meal (Week 24) (n=177, 186) 137.4  (24.96) 132.4  (25.17)
Morning 2 hours Post-meal (Week 0) (n=194, 201) 207.1  (54.74) 213.6  (53.95)
Morning 2 hours Post-meal (Week 12) (n=187, 190) 179.6  (46.17) 176.5  (43.69)
Morning 2 hours Post-meal (Week 24) (n=176, 184) 169.7  (39.04) 165.8  (35.77)
Midday Pre-meal (Week 0) (n=195, 200) 160.7  (47.89) 164.9  (48.71)
Midday Pre-meal (Week 12) (n=187, 190) 142.5  (37.27) 149.4  (41.58)
Midday Pre-meal (Week 24) (n=177, 186) 139.5  (31.05) 142.1  (32.73)
Midday 2 hours Post-meal (Week 0) (n=194, 201) 219.7  (54.03) 227.5  (54.56)
Midday 2 hours Post-meal (Week 12) (n=186, 189) 162.5  (41.53) 177.2  (44.53)
Midday 2 hours Post-meal (Week 24) (n=175, 184) 161.9  (38.66) 171.1  (39.33)
Evening Pre-meal (Week 0) (n=195, 200) 186.6  (44.97) 190.0  (53.41)
Evening Pre-meal (Week 12) (n=187, 190) 148.1  (33.74) 157.6  (42.00)
Evening Pre-meal (Week 24) (n=177, 186) 145.0  (30.67) 151.1  (33.36)
Evening 2 hours Post-meal (Week 0) (n=194, 201) 204.8  (54.31) 209.9  (58.59)
Evening 2 hours Post-meal (Week 12) (n=186, 190) 177.1  (45.29) 176.2  (40.55)
Evening 2 hours Post-meal (Week 24)(n=176, 185) 172.0  (38.77) 165.6  (38.66)
0300 Hours (3 am) (Week 0) (n=185, 193) 175.9  (51.97) 180.0  (54.35)
0300 Hours (3 am) (Week 12) (n=177, 185) 150.3  (39.41) 163.6  (42.42)
0300 Hours (3 am) (Week 24) (n=171, 179) 145.1  (31.45) 155.8  (34.36)
5.Secondary Outcome
Title Daily Dose of Insulin: Total, Basal, and Prandial
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug. Last observation carried forward (LOCF) principle was used.
Arm/Group Title Premixed Insulin Basal-Bolus
Hide Arm/Group Description:

Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)

Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks

Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks

Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks

Overall Number of Participants Analyzed 197 202
Mean (Standard Deviation)
Unit of Measure: International Units (IU)
Total Daily Dose 52.9  (19.72) 54.0  (19.00)
Daily Insulin Dose Basal 31.539  (11.9288) 24.717  (9.9304)
Daily Insulin Dose Bolus (prandial) 21.385  (7.8823) 29.269  (10.8353)
6.Secondary Outcome
Title Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks
Hide Description Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) using change from baseline in BMI at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline BMI value as a covariate and participants as a random effect.
Time Frame Baseline, 12 weeks, and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug and had baseline and at least 1 post-baseline BMI data.
Arm/Group Title Premixed Insulin Basal-Bolus
Hide Arm/Group Description:

Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)

Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks

Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks

Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks

Overall Number of Participants Analyzed 197 202
Least Squares Mean (95% Confidence Interval)
Unit of Measure: kilogram per square meter (kg/m^2)
Change at 12 weeks
0.26
(0.16 to 0.37)
0.20
(0.10 to 0.30)
Change at 24 weeks
0.31
(0.19 to 0.42)
0.29
(0.18 to 0.40)
7.Secondary Outcome
Title Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug. Last observation carried forward (LOCF) principle was used.
Arm/Group Title Premixed Insulin Basal-Bolus
Hide Arm/Group Description:

Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)

Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks

Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks

Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks

Overall Number of Participants Analyzed 197 202
Mean (Standard Deviation)
Unit of Measure: International Units per kilogram (IU/kg)
Total Daily Dose 0.738  (0.2477) 0.760  (0.2694)
Daily Insulin Dose Basal 0.440  (0.1498) 0.348  (0.1390)
Daily Insulin Dose Bolus (prandial) 0.298  (0.0994) 0.412  (0.1542)
8.Secondary Outcome
Title Percentage of Participants With Hypoglycemic Episodes (Incidence)
Hide Description Incidence of hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to study drug. Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L).
Time Frame baseline through 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the safety analyses population: participants who had been randomized and received at least one dose of study drug.
Arm/Group Title Premixed Insulin Basal-Bolus
Hide Arm/Group Description:

Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)

Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks

Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks

Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks

Overall Number of Participants Analyzed 197 202
Measure Type: Number
Unit of Measure: percentage of participants
54.8 55.0
9.Secondary Outcome
Title The Rate of Hypoglycemic Episodes
Hide Description The rate of hypoglycemic episodes is defined as the mean number of hypoglycemic episodes per 30 days per participant. Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L).
Time Frame baseline through 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the safety analyses population: participants who had been randomized and received at least one dose of study drug.
Arm/Group Title Premixed Insulin Basal-Bolus
Hide Arm/Group Description:

Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)

Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks

Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks

Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks

Overall Number of Participants Analyzed 197 202
Mean (Standard Error)
Unit of Measure: hypoglycemic episode/30 days/participant
0.468  (1.0417) 0.409  (0.6668)
10.Secondary Outcome
Title Percentage of Participants Experiencing a Severe Hypoglycemic Episode
Hide Description Severe hypoglycemic episode is defined as any event requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. The percentage of participants experiencing a severe hypoglycemic episode is defined as the 100 multiplied by the number of participants experiencing a severe hypoglycemic episode divided by the number of participants exposed to study drug.
Time Frame baseline through 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the safety analyses population: participants who had been randomized and received at least one dose of study drug.
Arm/Group Title Premixed Insulin Basal-Bolus
Hide Arm/Group Description:

Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)

Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks

Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks

Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks

Overall Number of Participants Analyzed 197 202
Measure Type: Number
Unit of Measure: Percentage of participants
0.0 0.0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Premixed Insulin Basal-Bolus
Hide Arm/Group Description

Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)

Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks

Once daily (bedtime) insulin glargine and three pre-meal insulin lispro

Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks

Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks

All-Cause Mortality
Premixed Insulin Basal-Bolus
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Premixed Insulin Basal-Bolus
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/197 (6.60%)      8/202 (3.96%)    
Cardiac disorders     
Acute myocardial infarction  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Angina pectoris  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Atrial fibrillation  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Cardiac failure chronic  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Coronary artery disease  1  1/197 (0.51%)  1 1/202 (0.50%)  1
Ear and labyrinth disorders     
Sudden hearing loss  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Hepatobiliary disorders     
Alcoholic liver disease  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Cholecystitis  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Infections and infestations     
Cellulitis  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Pyelonephritis acute  1  1/197 (0.51%)  1 1/202 (0.50%)  1
Injury, poisoning and procedural complications     
Accident  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Ankle fracture  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Fall  1  2/197 (1.02%)  2 0/202 (0.00%)  0
Patella fracture  1  2/197 (1.02%)  2 0/202 (0.00%)  0
Wound complication  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Metabolism and nutrition disorders     
Diabetes mellitus  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Hypoglycaemia  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Type 2 diabetes mellitus  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Nervous system disorders     
Cerebral infarction  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Cerebrovascular accident  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Cerebrovascular insufficiency  1  1/197 (0.51%)  1 0/202 (0.00%)  0
VIIth nerve paralysis  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Renal and urinary disorders     
Nephrolithiasis  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Vascular disorders     
Arteriosclerosis  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Diabetic vascular disorder  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Premixed Insulin Basal-Bolus
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   60/197 (30.46%)      60/202 (29.70%)    
Blood and lymphatic system disorders     
Leukocytosis  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Thrombocytopenia  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Cardiac disorders     
Angina pectoris  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Coronary artery disease  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Extrasystoles  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Eye disorders     
Cataract  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Conjunctivitis allergic  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Diabetic retinopathy  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Eye pain  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Keratitis  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Retinal haemorrhage  1  0/197 (0.00%)  0 2/202 (0.99%)  2
Vitreous haemorrhage  1  1/197 (0.51%)  1 1/202 (0.50%)  1
Gastrointestinal disorders     
Abdominal discomfort  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Abdominal distension  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Abdominal pain  1  2/197 (1.02%)  2 1/202 (0.50%)  1
Abdominal pain upper  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Cheilitis  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Constipation  1  1/197 (0.51%)  1 1/202 (0.50%)  1
Diarrhoea  1  1/197 (0.51%)  1 5/202 (2.48%)  6
Gastric disorder  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Gastritis  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Gastrointestinal haemorrhage  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Gastrointestinal motility disorder  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Gastrooesophageal reflux disease  1  1/197 (0.51%)  1 1/202 (0.50%)  1
Hyperchlorhydria  1  1/197 (0.51%)  6 0/202 (0.00%)  0
Hypoaesthesia oral  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Loose tooth  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Mouth ulceration  1  1/197 (0.51%)  1 1/202 (0.50%)  1
Nausea  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Peptic ulcer  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Toothache  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Vomiting  1  1/197 (0.51%)  1 0/202 (0.00%)  0
General disorders     
Chest discomfort  1  3/197 (1.52%)  3 0/202 (0.00%)  0
Oedema  1  1/197 (0.51%)  1 1/202 (0.50%)  1
Pain  1  1/197 (0.51%)  1 1/202 (0.50%)  1
Pyrexia  1  1/197 (0.51%)  1 1/202 (0.50%)  1
Hepatobiliary disorders     
Cholecystitis  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Hepatic function abnormal  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Hepatic steatosis  1  1/197 (0.51%)  1 1/202 (0.50%)  1
Infections and infestations     
Acute sinusitis  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Acute tonsillitis  1  1/197 (0.51%)  1 1/202 (0.50%)  1
Bacterial infection  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Cervicitis  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Cystitis  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Gastroenteritis  1  1/197 (0.51%)  1 1/202 (0.50%)  1
Herpes zoster  1  2/197 (1.02%)  2 0/202 (0.00%)  0
Localised infection  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Lung infection  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Nasopharyngitis  1  15/197 (7.61%)  16 17/202 (8.42%)  19
Otitis media  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Periodontitis  1  2/197 (1.02%)  2 0/202 (0.00%)  0
Pharyngitis  1  3/197 (1.52%)  3 2/202 (0.99%)  2
Pneumonia  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Tonsillitis  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Tooth abscess  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Upper respiratory tract infection  1  7/197 (3.55%)  10 10/202 (4.95%)  12
Urinary tract infection  1  1/197 (0.51%)  1 3/202 (1.49%)  3
Vaginal infection  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Injury, poisoning and procedural complications     
Contusion  1  1/197 (0.51%)  1 1/202 (0.50%)  2
Excoriation  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Foot fracture  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Limb injury  1  2/197 (1.02%)  2 0/202 (0.00%)  0
Nail injury  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Open wound  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Blood potassium decreased  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Weight decreased  1  1/197 (0.51%)  1 1/202 (0.50%)  1
Weight increased  1  3/197 (1.52%)  3 0/202 (0.00%)  0
Metabolism and nutrition disorders     
Dyslipidaemia  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Hypercholesterolaemia  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Hyperlipidaemia  1  2/197 (1.02%)  2 0/202 (0.00%)  0
Hyperuricaemia  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Obesity  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/197 (0.51%)  1 1/202 (0.50%)  1
Back pain  1  1/197 (0.51%)  1 2/202 (0.99%)  2
Intervertebral disc degeneration  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Intervertebral disc protrusion  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Lumbar spinal stenosis  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Muscle spasms  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Osteoarthritis  1  1/197 (0.51%)  1 1/202 (0.50%)  1
Pain in extremity  1  1/197 (0.51%)  1 1/202 (0.50%)  1
Rheumatoid arthritis  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Synovitis  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Tenosynovitis  1  1/197 (0.51%)  1 1/202 (0.50%)  1
Trigger finger  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Skin papilloma  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Thyroid neoplasm  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Nervous system disorders     
Carpal tunnel syndrome  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Cerebral infarction  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Cerebral ischaemia  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Dizziness  1  4/197 (2.03%)  7 6/202 (2.97%)  6
Headache  1  2/197 (1.02%)  2 2/202 (0.99%)  3
Hypoaesthesia  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Hypogeusia  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Poor quality sleep  1  1/197 (0.51%)  1 1/202 (0.50%)  1
Syncope  1  0/197 (0.00%)  0 1/202 (0.50%)  1
VIIth nerve paralysis  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Psychiatric disorders     
Depression  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Insomnia  1  3/197 (1.52%)  3 1/202 (0.50%)  1
Nervousness  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Renal and urinary disorders     
Nephrolithiasis  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Cough  1  3/197 (1.52%)  3 1/202 (0.50%)  1
Dyspnoea  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Epistaxis  1  0/197 (0.00%)  0 1/202 (0.50%)  2
Oropharyngeal pain  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Rhinorrhoea  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatitis allergic  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Diabetic foot  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Eczema  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Pruritus  1  1/197 (0.51%)  1 0/202 (0.00%)  0
Rash  1  0/197 (0.00%)  0 2/202 (0.99%)  2
Urticaria  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Urticaria papular  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Vascular disorders     
Arteriosclerosis  1  0/197 (0.00%)  0 1/202 (0.50%)  1
Hypertension  1  2/197 (1.02%)  2 0/202 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01175811     History of Changes
Other Study ID Numbers: 13492
F3Z-CR-IOQD ( Other Identifier: Eli Lilly and Company )
First Submitted: August 3, 2010
First Posted: August 5, 2010
Results First Submitted: October 29, 2013
Results First Posted: December 18, 2013
Last Update Posted: December 18, 2013