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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01175811
First received: August 3, 2010
Last updated: October 29, 2013
Last verified: October 2013

August 3, 2010
October 29, 2013
February 2011
November 2012   (final data collection date for primary outcome measure)
Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
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.
Change in Haemoglobin A1c (HbA1c) from baseline to 24 week endpoint [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01175811 on ClinicalTrials.gov Archive Site
  • Change in HbA1c From Baseline to 12 Week Endpoint [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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.
  • 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 [ Time Frame: 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    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.
  • The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. [ Time Frame: Baseline, 12 weeks, and 24 weeks ] [ Designated as safety issue: No ]
    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.
  • Daily Dose of Insulin: Total, Basal, and Prandial [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks [ Time Frame: Baseline, 12 weeks, and 24 weeks ] [ Designated as safety issue: No ]
    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.
  • Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants With Hypoglycemic Episodes (Incidence) [ Time Frame: baseline through 24 weeks ] [ Designated as safety issue: Yes ]
    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).
  • The Rate of Hypoglycemic Episodes [ Time Frame: baseline through 24 weeks ] [ Designated as safety issue: Yes ]
    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).
  • Percentage of Participants Experiencing a Severe Hypoglycemic Episode [ Time Frame: baseline through 24 weeks ] [ Designated as safety issue: Yes ]
    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.
  • Change in HbA1c from baseline to 12 week endpoint [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • The percentage of patients who achieved HbA1c less than or equal to 6.5% and less than or equal to7% at 12 weeks and 24 weeks [ Time Frame: 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • The 7-point self-monitored blood glucose (SMBG) profiles at baseline, 12 weeks and 24 weeks. [ Time Frame: Baseline, 12 weeks, and 24 weeks ] [ Designated as safety issue: No ]
  • Daily dose of insulin: total, basal, and prandial [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in Body Mass Index (BMI) from baseline to 12 and 24 weeks [ Time Frame: Baseline, 12 weeks, and 24 weeks ] [ Designated as safety issue: No ]
  • Daily Dose of insulin per kilogram of body weight: total, basal and prandial [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • The incidence of hypoglycemic episodes [ Time Frame: over 24 weeks ] [ Designated as safety issue: Yes ]
  • The rate of hypoglycemic episodes [ Time Frame: over 24 weeks ] [ Designated as safety issue: Yes ]
  • The severity of hypoglycemic episodes [ Time Frame: over 24 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Study Comparing Insulin Intensification Therapies in Patients With Type 2 Diabetes Mellitus
A Comparison of Premixed and Basal-Bolus Insulin Intensification Therapies in Patients With Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Twice-daily Premixed Insulin

The purpose of the study is to compare the effects on overall glycaemic control of two insulin intensification therapies.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Insulin Lispro Premix
    Participant dependent dose, administered subcutaneously for 24 weeks
    Other Names:
    • Humalog Mix25
    • Humalog Mix50
    • LY275585
  • Drug: Insulin Glargine
    Participant dependent dose, administered subcutaneously for 24 weeks
  • Drug: Insulin Lispro
    Participant dependent dose, administered subcutaneously for 24 weeks
    Other Names:
    • Humalog
    • LY275585
  • Experimental: Premixed Insulin
    Twice daily (before breakfast and lunch) insulin lispro mix 50 (50% insulin lispro, 50% insulin lispro protamine suspension [LM50]) and once daily (before dinner) insulin lispro mix 25 (25% insulin lispro, 75% insulin lispro protamine suspension [LM25])
    Intervention: Drug: Insulin Lispro Premix
  • Active Comparator: Basal-Bolus
    Once daily (bedtime) insulin glargine and three pre-meal insulin lispro
    Interventions:
    • Drug: Insulin Glargine
    • Drug: Insulin Lispro
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
402
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Present with type 2 diabetes mellitus
  • Have been receiving twice-daily premixed insulin therapy with or without metformin and/or alpha-glucosidase inhibitors, for at least six months prior to study entry
  • Have Haemoglobin A1c (HbA1c) >7.0% and <12.0%

Exclusion Criteria:

  • Within the last 3 months prior to entry into the study, are taking any non-permitted glucose-lowering agents, or are taking any non-permitted oral antihyperglycaemic medications
  • Are pregnant or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
  • Are women who are breastfeeding.
  • Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night).
  • Do not regularly consume three meals per day.
  • Have a body mass index >35 kilogram per square meter (kg/m^2).
  • Have had more than one episode of severe hypoglycaemia within 24 weeks prior to entry into the study.
  • Have cardiac disease with a functional status that is Class III or IV
  • Have a history of renal or liver disease
  • Have used less than or equal to 20 Units per day (U/day) of insulin during the past 90 days for more than 14 days (accumulated).
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of,   China,   Taiwan
 
NCT01175811
13492, F3Z-CR-IOQD
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP