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

Eli Lilly and Company402 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

402

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Lispro PremixDRUG

Participant dependent dose, administered subcutaneously for 24 weeks

Insulin GlargineDRUG

Participant dependent dose, administered subcutaneously for 24 weeks

Insulin LisproDRUG

Participant dependent dose, administered subcutaneously for 24 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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).

Locations (14)

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

Change in HbA1c From Baseline to 12 Week Endpoint

Time frame: Baseline, 12 weeks

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

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

The 7-point Self-monitored Blood Glucose (SMBG) Profiles at 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.

Data from ClinicalTrials.gov

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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

Guangzhou, China

Kunming, China

Nanjing, China

Shanghai, China

Xi'an, China

Daegu, South Korea

Goyang-si, South Korea

Seoul, South Korea

Yeongdeungpo-gu, South Korea

...and 4 more locations

Time frame: Baseline, 12 weeks, and 24 weeks

Daily Dose of Insulin: Total, Basal, and Prandial

Time frame: 24 weeks

Change in Body Mass Index (BMI) From Baseline to 12 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.

Time frame: Baseline, 12 weeks, and 24 weeks

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

Time frame: 24 weeks

Percentage of Participants With Hypoglycemic Episodes (Incidence)

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

The Rate of Hypoglycemic Episodes

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

Percentage of Participants Experiencing a Severe Hypoglycemic Episode

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