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Trial record 1 of 1 for:    EFC12347
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Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy (EDITION III)

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ClinicalTrials.gov Identifier: NCT01676220
Recruitment Status : Completed
First Posted : August 30, 2012
Results First Posted : April 23, 2015
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: HOE901-U300 (new formulation of insulin glargine)
Drug: Lantus (insulin glargine)
Enrollment 878
Recruitment Details A total of 1396 participants were screened, of whom 518 participants were screen failure and 878 participants were randomized.
Pre-assignment Details  
Arm/Group Title HOE901-U300 Lantus (Insulin Glargine)
Hide Arm/Group Description HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s). Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).
Period Title: Overall Study
Started 439 439
Treated 435 438
Modified Intent-To-Treat Population 432 [1] 430 [1]
Completed 337 314
Not Completed 102 125
Reason Not Completed
Randomized But Not Treated             4             1
Adverse Event             10             8
Lack of Efficacy             2             5
Protocol Violation             11             12
Received Rescue Therapy             14             22
Personal Reason             34             45
Lost to Follow-up             11             18
Selection Criterion/Protocol Violation             9             9
Site Closure/Site Withdrawal             1             4
Perceived Lack of Efficacy             3             1
Non Serious Hypoglycemia             2             0
No More Need of Insulin             1             0
[1]
Participants who received at least 1 dose of drug, had both baseline, at least 1 post­baseline data
Arm/Group Title HOE901-U300 Lantus Total
Hide Arm/Group Description HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s). Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s). Total of all reporting groups
Overall Number of Baseline Participants 439 439 878
Hide Baseline Analysis Population Description
Randomized population: all screened participants (who originally met inclusion criteria and signed informed consent) allocated to a treatment group and recorded in Interactive Voice/Web Response System (IVRS/IWRS) database, regardless of whether treatment was used or not. Participants were analyzed in treatment group to which they were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 439 participants 439 participants 878 participants
58.2  (9.9) 57.2  (10.3) 57.7  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 439 participants 439 participants 878 participants
Female
186
  42.4%
185
  42.1%
371
  42.3%
Male
253
  57.6%
254
  57.9%
507
  57.7%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter
Number Analyzed 439 participants 439 participants 878 participants
32.8  (6.9) 33.2  (6.6) 33.0  (6.7)
Duration of Diabetes   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 439 participants 439 participants 878 participants
10.11  (6.49) 9.57  (6.22) 9.84  (6.36)
[1]
Measure Description: Number of participants analyzed for this baseline characteristics = 435 and 436 in HOE901-U300 and Lantus arm, respectively.
Basal Insulin Daily Dose   [1] 
Mean (Standard Deviation)
Unit of measure:  Units per kilogram (U/kg)
Number Analyzed 439 participants 439 participants 878 participants
0.193  (0.027) 0.193  (0.034) 0.193  (0.031)
[1]
Measure Description: Number of participants analyzed for this baseline characteristics = 432 and 436 in HOE901-U300 and Lantus arm, respectively.
Glycated Hemoglobin A1c (HbA1c)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 439 participants 439 participants 878 participants
Less Than (<) 8% 141 142 283
Greater Than or Equal to (>=) 8% 298 297 595
1.Primary Outcome
Title Change in HbA1c From Baseline to Month 6 Endpoint
Hide Description Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT) population:randomized participants who received at least 1 dose, had baseline and at least 1 post-baseline data of any efficacy variable, irrespective of compliance. Number of participants analyzed=participants included in mITT population with baseline and at least 1 post-baseline HbA1c data (Week 12 and/or Month 6).
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Overall Number of Participants Analyzed 402 394
Least Squares Mean (Standard Error)
Unit of Measure: percentage of hemoglobin
-1.42  (0.047) -1.46  (0.048)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HOE901-U300, Lantus
Comments Analysis was performed using mixed model for repeated measurements (MMRM) with treatment groups, strata of screening HbA1c (<8.0, >=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline HbA1c and baseline HbA1c-by-visit interaction as continuous fixed covariates.
Type of Statistical Test Non-Inferiority or Equivalence
Comments

Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially:

  1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is <0.4%.
  2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is <0.
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.090 to 0.174
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.067
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6
Hide Description Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]). Only nocturnal hypoglycemia occurring before initiation of rescue therapy were considered in the analysis. Week 9 and Month 6 value correspond to the observed value at Week 9 and Month 6 visit respectively.
Time Frame Week 9 Up to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population.
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Overall Number of Participants Analyzed 432 430
Measure Type: Number
Unit of Measure: percentage of participants
15.5 17.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HOE901-U300, Lantus
Comments A one-sided test (at alpha=0.025) for superiority of HOE901-U300 over Lantus was to be performed in case the non-inferiority of HOE901-U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method stratified by randomization strata of screening HbA1c (<8.0, >=8.0%), randomization strata of geographical region (Non-Japan; Japan).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4536
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.66 to 1.20
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint
Hide Description Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Except for baseline value average of preinjection SMPG was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Number of participants analyzed = participants included in the mITT population with baseline and at least one pre-injection SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6)
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Overall Number of Participants Analyzed 207 222
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-2.16  (0.162) -2.33  (0.156)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HOE901-U300, Lantus
Comments Change in pre-injection SMPG was analyzed using MMRM model with treatment groups, strata of screening HbA1c (<8.0, >=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline preinjection SMPG value and baseline preinjection SMPG value-by-visit interaction as continuous fixed covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
-0.275 to 0.605
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.224
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Variability of Preinjection SMPG at Month 6 Endpoint
Hide Description Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Number of participants analyzed = participants included in the mITT Population with at least one pre-injection SMPG variability assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Overall Number of Participants Analyzed 422 418
Least Squares Mean (Standard Error)
Unit of Measure: percentage of mean
18.70  (0.502) 18.33  (0.521)
5.Secondary Outcome
Title Percentage of Participants With HbA1c <7% at Month 6
Hide Description Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Participants without any available Month 6 HbA1C assessment were considered as failures (non-responders).
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Overall Number of Participants Analyzed 432 430
Measure Type: Number
Unit of Measure: percentage of participants
43.1 42.1
6.Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint
Hide Description Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline FPG assessment (Week 12 and/or Month 6).
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Overall Number of Participants Analyzed 398 387
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-3.41  (0.103) -3.80  (0.105)
7.Secondary Outcome
Title Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6
Hide Description Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Participants without any available FPG assessment at Month 6 were considered as failures (non-responders).
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Overall Number of Participants Analyzed 432 430
Measure Type: Number
Unit of Measure: percentage of participants
26.2 29.5
8.Secondary Outcome
Title Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6
Hide Description Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 8-point SMPG profiles measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Only participants from the mITT population with a value at baseline and at specified timepoint were analyzed (represented by n=X, X in the category titles).
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Overall Number of Participants Analyzed 432 430
Mean (Standard Deviation)
Unit of Measure: mmol/L
03:00 at Night Plasma Glucose (n=281,277) -2.63  (3.24) -3.01  (3.75)
Pre-Breakfast Plasma Glucose (n=292,286) -3.28  (2.72) -3.72  (2.96)
2 Hours After Breakfast Plasma Glucose (n=278,278) -3.69  (3.65) -4.08  (4.03)
Pre-Lunch Plasma Glucose (n=289,281) -2.58  (3.39) -3.39  (3.76)
2 Hours After Lunch Plasma Glucose (n=280,269) -2.19  (3.88) -3.13  (3.77)
Pre-Dinner Plasma Glucose (n=291,285) -2.57  (3.49) -2.43  (3.79)
2 Hours After Dinner Plasma Glucose (n=282,269) -2.36  (3.89) -2.33  (4.03)
Bedtime Plasma Glucose (n=249,249) -2.19  (3.75) -2.26  (3.66)
9.Secondary Outcome
Title Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint
Hide Description Change in 24-hour average of 8-point SMPG profile. 8-point SMPG was assessed at: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 24-hour average 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline 24-hour average 8-point SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 SC injection once daily for 12 months on top of non-insulin antihyperglycemic drug(s).
Lantus SC injection once daily for 12 months on top of non-insulin antihyperglycemic drug(s).
Overall Number of Participants Analyzed 381 393
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-2.72  (0.088) -2.90  (0.089)
10.Secondary Outcome
Title Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint
Hide Description Variability is assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 5 measurements of the 8-point profiles. Only variability of 24-hour 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline variability of 24-hour average 8-point SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Overall Number of Participants Analyzed 381 393
Least Squares Mean (Standard Error)
Unit of Measure: percentage of mean
1.53  (0.643) 1.41  (0.647)
11.Secondary Outcome
Title Change in Daily Basal Insulin Dose From Baseline to Month 6
Hide Description Only insulin dose measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Number of participants analyzed = participants included in the mITT population with Baseline and Month 6 basal insulin dose assessment.
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Overall Number of Participants Analyzed 362 340
Mean (Standard Deviation)
Unit of Measure: U/kg
0.43  (0.29) 0.34  (0.24)
12.Secondary Outcome
Title Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint
Hide Description DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. Only DTSQ total score measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Number of participants analyzed = participants included in the mITT population with Baseline and at least one post-baseline DTSQ assessment (Week 12 and/or Month 6).
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Overall Number of Participants Analyzed 371 367
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
4.89  (0.246) 5.12  (0.251)
13.Secondary Outcome
Title Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12
Hide Description Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Overall Number of Participants Analyzed 435 438
Measure Type: Number
Unit of Measure: percentage of participants
Any Hypoglycemia Event: All Hypoglycemia 58.9 63.2
Severe Hypoglycemia: All Hypoglycemia 1.4 2.1
Documented Symptomatic: All Hypoglycemia 39.1 44.1
Asymptomatic: All Hypoglycemia 41.6 46.8
Probable Symptomatic: All Hypoglycemia 3.2 3.0
Relative: All Hypoglycemia 10.6 11.6
Severe and/or Confirmed: All Hypoglycemia 56.3 61.2
Any Hypoglycemia Event: Nocturnal Hypoglycemia 27.6 30.1
Severe Hypoglycemia: Nocturnal Hypoglycemia 0.0 0.7
Documented Symptomatic: Nocturnal Hypoglycemia 18.6 20.8
Asymptomatic: Nocturnal Hypoglycemia 13.3 16.0
Probable Symptomatic: Nocturnal Hypoglycemia 0.7 0.0
Relative: Nocturnal Hypoglycemia 4.4 3.2
Severe and/or Confirmed: Nocturnal Hypoglycemia 25.3 29.5
Time Frame All Adverse Events (AE) were collected from signature of informed consent form up to study completion regardless of seriousness or relationship to study drug.
Adverse Event Reporting Description Reported adverse events are treatment­emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first injection of study drug up to 2 day after the last injection of study drug). Analysis was done on safety population.
 
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description HOE901­U300 SC injection once daily for 12 months in combination with non­insulin antihyperglycemic drug(s). Lantus SC injection once daily for 12 months in combination with non­insulin antihyperglycemic drug(s).
All-Cause Mortality
HOE901-U300 Lantus
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HOE901-U300 Lantus
Affected / at Risk (%) Affected / at Risk (%)
Total   35/435 (8.05%)   39/438 (8.90%) 
Cardiac disorders     
Acute myocardial infarction  1  1/435 (0.23%)  2/438 (0.46%) 
Angina pectoris  1  1/435 (0.23%)  2/438 (0.46%) 
Angina unstable  1  1/435 (0.23%)  1/438 (0.23%) 
Arteriosclerosis coronary artery  1  1/435 (0.23%)  0/438 (0.00%) 
Atrial fibrillation  1  2/435 (0.46%)  1/438 (0.23%) 
Cardiac failure congestive  1  1/435 (0.23%)  1/438 (0.23%) 
Coronary artery disease  1  2/435 (0.46%)  0/438 (0.00%) 
Myocardial infarction  1  1/435 (0.23%)  1/438 (0.23%) 
Ventricular tachycardia  1  1/435 (0.23%)  0/438 (0.00%) 
Endocrine disorders     
Goitre  1  1/435 (0.23%)  1/438 (0.23%) 
Eye disorders     
Cataract  1  0/435 (0.00%)  1/438 (0.23%) 
Retinal detachment  1  0/435 (0.00%)  1/438 (0.23%) 
Gastrointestinal disorders     
Abdominal hernia  1  1/435 (0.23%)  0/438 (0.00%) 
Abdominal pain  1  0/435 (0.00%)  3/438 (0.68%) 
Colitis ischaemic  1  0/435 (0.00%)  1/438 (0.23%) 
Diverticulum intestinal  1  1/435 (0.23%)  0/438 (0.00%) 
Duodenal ulcer  1  1/435 (0.23%)  0/438 (0.00%) 
Gastric ulcer haemorrhage  1  0/435 (0.00%)  1/438 (0.23%) 
Gastrointestinal haemorrhage  1  0/435 (0.00%)  2/438 (0.46%) 
Haemorrhoids  1  1/435 (0.23%)  0/438 (0.00%) 
Pancreatitis  1  1/435 (0.23%)  0/438 (0.00%) 
Peptic ulcer  1  0/435 (0.00%)  1/438 (0.23%) 
Small intestinal obstruction  1  1/435 (0.23%)  0/438 (0.00%) 
Umbilical hernia  1  0/435 (0.00%)  1/438 (0.23%) 
General disorders     
Non-cardiac chest pain  1  2/435 (0.46%)  0/438 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  1/435 (0.23%)  0/438 (0.00%) 
Infections and infestations     
Cystitis  1  1/435 (0.23%)  0/438 (0.00%) 
Diabetic foot infection  1  0/435 (0.00%)  1/438 (0.23%) 
Diverticulitis  1  2/435 (0.46%)  0/438 (0.00%) 
Liver abscess  1  1/435 (0.23%)  0/438 (0.00%) 
Lobar pneumonia  1  0/435 (0.00%)  1/438 (0.23%) 
Lung infection  1  0/435 (0.00%)  1/438 (0.23%) 
Pneumonia  1  0/435 (0.00%)  1/438 (0.23%) 
Postoperative wound infection  1  1/435 (0.23%)  0/438 (0.00%) 
Pulmonary mycosis  1  1/435 (0.23%)  0/438 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  1/435 (0.23%)  0/438 (0.00%) 
Limb injury  1  0/435 (0.00%)  1/438 (0.23%) 
Multiple injuries  1  1/435 (0.23%)  0/438 (0.00%) 
Rib fracture  1  1/435 (0.23%)  0/438 (0.00%) 
Road traffic accident  1  1/435 (0.23%)  0/438 (0.00%) 
Upper limb fracture  1  1/435 (0.23%)  0/438 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  1/435 (0.23%)  0/438 (0.00%) 
Blood bilirubin increased  1  1/435 (0.23%)  0/438 (0.00%) 
Metabolism and nutrition disorders     
Hypoglycaemia  1  0/435 (0.00%)  1/438 (0.23%) 
Musculoskeletal and connective tissue disorders     
Arthritis  1  0/435 (0.00%)  1/438 (0.23%) 
Chondrocalcinosis pyrophosphate  1  0/435 (0.00%)  1/438 (0.23%) 
Flank pain  1  0/435 (0.00%)  1/438 (0.23%) 
Musculoskeletal chest pain  1  1/435 (0.23%)  0/438 (0.00%) 
Osteoarthritis  1  1/435 (0.23%)  2/438 (0.46%) 
Pain in extremity  1  1/435 (0.23%)  0/438 (0.00%) 
Spinal osteoarthritis  1  1/435 (0.23%)  0/438 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  0/435 (0.00%)  1/438 (0.23%) 
Breast cancer  1  0/435 (0.00%)  1/438 (0.23%) 
Prostate cancer  1  1/435 (0.23%)  1/438 (0.23%) 
Nervous system disorders     
Carotid artery aneurysm  1  0/435 (0.00%)  1/438 (0.23%) 
Cerebral artery embolism  1  0/435 (0.00%)  1/438 (0.23%) 
Cerebral infarction  1  0/435 (0.00%)  1/438 (0.23%) 
Cerebrovascular accident  1  0/435 (0.00%)  1/438 (0.23%) 
Convulsion  1  0/435 (0.00%)  1/438 (0.23%) 
Hypoglycaemic unconsciousness  1  0/435 (0.00%)  1/438 (0.23%) 
Ischaemic stroke  1  0/435 (0.00%)  1/438 (0.23%) 
Syncope  1  1/435 (0.23%)  1/438 (0.23%) 
Renal and urinary disorders     
Haematuria  1  0/435 (0.00%)  1/438 (0.23%) 
Nephrolithiasis  1  2/435 (0.46%)  0/438 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  0/435 (0.00%)  1/438 (0.23%) 
Menorrhagia  1  1/435 (0.23%)  0/438 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  0/435 (0.00%)  1/438 (0.23%) 
Acute respiratory failure  1  1/435 (0.23%)  0/438 (0.00%) 
Asthma  1  1/435 (0.23%)  0/438 (0.00%) 
Chronic obstructive pulmonary disease  1  0/435 (0.00%)  2/438 (0.46%) 
Dyspnoea  1  1/435 (0.23%)  0/438 (0.00%) 
Interstitial lung disease  1  0/435 (0.00%)  1/438 (0.23%) 
Sleep apnoea syndrome  1  1/435 (0.23%)  0/438 (0.00%) 
Surgical and medical procedures     
Medical device removal  1  0/435 (0.00%)  1/438 (0.23%) 
Vascular disorders     
Peripheral arterial occlusive disease  1  1/435 (0.23%)  0/438 (0.00%) 
Varicose vein  1  1/435 (0.23%)  0/438 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HOE901-U300 Lantus
Affected / at Risk (%) Affected / at Risk (%)
Total   115/435 (26.44%)   107/438 (24.43%) 
Infections and infestations     
Nasopharyngitis  1  41/435 (9.43%)  47/438 (10.73%) 
Sinusitis  1  11/435 (2.53%)  23/438 (5.25%) 
Upper respiratory tract infection  1  45/435 (10.34%)  34/438 (7.76%) 
Nervous system disorders     
Headache  1  36/435 (8.28%)  22/438 (5.02%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 17.0
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.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01676220     History of Changes
Other Study ID Numbers: EFC12347
2012-000146-35 ( EudraCT Number )
U1111-1124-5261 ( Other Identifier: UTN )
First Submitted: August 28, 2012
First Posted: August 30, 2012
Results First Submitted: March 24, 2015
Results First Posted: April 23, 2015
Last Update Posted: June 24, 2015