Skip to main content
OpenTrials
Completed

NCT Number: NCT00560417

Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide

This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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., Ponce, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must have type 2 diabetes
  • Must be at least 18 years of age and less than 75 years of age
  • Must be taking exenatide 10 micrograms twice a day (BID) for at least 3 months
  • Must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione (TZD). Doses must be at or above the following: Metformin--1500 mg/day, Sulfonylurea--1/2 the maximum daily dose according to the product label, TZD--30 mg/day pioglitazone
  • Must have a hemoglobin A1C greater than or equal to 7.0% and less than or equal to 10.0%

Exclusion criteria

  • Must not have used insulin on a regular basis during the past 2 years
  • Must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months
  • Must not have had more than one episode of severe hypoglycemia in the past 6 months
  • Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease
  • Must not be pregnant or intend to get pregnant during the course of the study

Treatment and study plan

Insulin Lispro Protamine Suspension

Drug

Administered subcutaneously once a day at bedtime

Other names: LY275585[P]

insulin glargine

Drug

Administered subcutaneously once a day at bedtime

Other names: Lantus

Primary outcomes

  1. Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])

    Time frame: Baseline, Endpoint (LOCF) up to 24 weeks

    Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.

Secondary outcomes

  1. Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)

    Time frame: 24 weeks, Endpoint (LOCF) up to 24 weeks

    Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.

  2. Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)

    Time frame: Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks

    Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.

  3. Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%

    Time frame: Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks

  4. 7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)

    Time frame: Baseline, Endpoint (LOCF) up to 24 weeks

    SMBG at morning pre-meal, morning post-prandial, midday pre-meal, midday post-prandial, evening pre-meal, evening postprandial, 0300 hours. Post-prandial glucose is measured 2 hours after the start of the meal.

  5. Glycemic Variability at Baseline and Endpoint (LOCF)

    Time frame: Baseline, Endpoint (LOCF) up to 24 weeks

    Glycemic variability was defined as the standard deviation (SD) of a participant's intra-day 7-point, self-monitored, blood glucose. Mean SD was calculated based on the SD for each participant in the study.

  6. Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)

    Time frame: Baseline to Endpoint (LOCF) up to 24 weeks

    Overall:any time after randomization.Episode:any time patient experienced sign/symptom associated with hypoglycemia, or had blood glucose level ≤70 mg/dL. Non-nocturnal:any episode that occurred between waking and bedtime. Nocturnal:any episode that occurred between bedtime and waking.Severe:episode with symptoms consistent with neuroglycopenia in which patient requires assistance,and is associated with:blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.Incidence(%)=(Number of patients experiencing episodes/number of patients in arm)*100.

  7. Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)

    Time frame: Baseline to Endpoint (LOCF) up to 24 weeks

    Rate of self-reported hypoglycemic episodes, all, non-nocturnal, and nocturnal, at Endpoint (LOCF) and overall. Rate is reported as episodes/participant/365 days. Episode = any time participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if it was not associated with signs, symptoms, or treatment. Overall=any time during the post-randomization visits within the study period. Nocturnal=Any episode that occurs between bedtime and waking. Non-Nocturnal=Any episode that occurs between waking and bedtime.

  8. Actual Body Weight at Baseline and Endpoint (LOCF)

    Time frame: Baseline, Endpoint (LOCF) up to 24 weeks

  9. Change From Baseline in Body Weight at Endpoint (LOCF)

    Time frame: Baseline, Endpoint (LOCF) up to 24 weeks

  10. Total Daily Insulin Dose at Endpoint (LOCF)

    Time frame: Endpoint (LOCF) up to 24 weeks

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized Trial Comparing Insulin Lispro Protamine Suspension With Insulin Glargine in Subjects With Type 2 Diabetes on Oral Antihyperglycemic Medications and Exenatide

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 19, 2007
Registry last updated
Jan 13, 2011

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.