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Completed

NCT Number: NCT01175811

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

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Insulin Lispro Premix

Drug

Participant dependent dose, administered subcutaneously for 24 weeks

Other names: Humalog Mix25, Humalog Mix50, LY275585

insulin glargine

Drug

Participant dependent dose, administered subcutaneously for 24 weeks

Insulin Lispro

Drug

Participant dependent dose, administered subcutaneously for 24 weeks

Other names: Humalog, LY275585

Primary outcomes

  1. Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint

    Time frame: Baseline, 24 weeks

    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.

Secondary outcomes

  1. Change in HbA1c From Baseline to 12 Week Endpoint

    Time frame: Baseline, 12 weeks

    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.

  2. 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

    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.

  3. The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.

    Time frame: Baseline, 12 weeks, and 24 weeks

    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.

  4. Daily Dose of Insulin: Total, Basal, and Prandial

    Time frame: 24 weeks

  5. Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks

    Time frame: Baseline, 12 weeks, and 24 weeks

    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.

  6. Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial

    Time frame: 24 weeks

  7. Percentage of Participants With Hypoglycemic Episodes (Incidence)

    Time frame: baseline through 24 weeks

    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).

  8. The Rate of Hypoglycemic Episodes

    Time frame: baseline through 24 weeks

    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).

  9. Percentage of Participants Experiencing a Severe Hypoglycemic Episode

    Time frame: baseline through 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 5, 2010
Registry last updated
Dec 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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