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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT00560417 (opens ClinicalTrials.gov in a new tab)Other id11647Other idF3Z-US-IOPB
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Exenatide (exendin-4), does not give it. It appears in the eligibility rules.

Overview

Status
Completed
Phase
Phase 3
Enrollment
339 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Open label (no masking)
Countries
2 countries

United States, Puerto Rico

Start
Nov 2007
Primary completion
Dec 2009
Completion
Dec 2009
First posted
19 Nov 2007 (estimated)
Last update posted
13 Jan 2011 (estimated)
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2007200820092010
  1. Ph 3

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

    NCT00560417

    Nov 2007 to Dec 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Insulin Lispro Protamine SuspensionDrug
  • Insulin GlargineDrug

Arms2

  • Active comparator

    ILPS

    Insulin Lispro Protamine Suspension (ILPS)

  • Active comparator

    Glargine

    Insulin Glargine

Primary outcomes1

Outcomes the sponsor listed as primary.

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

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

    Registry description

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

Secondary outcomes(10)

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

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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Endpoint (LOCF) up to 24 weeks

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

GroupValue (percent of glycosylated hemoglobin)Spread
ILPS8.480.04
Glargine8.470.04
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· 24 weeks, Endpoint (LOCF) up to 24 weeks

Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)

GroupValue (percent of glycosylated hemoglobin)Spread
ILPS6.940.07
Glargine6.700.06
Secondary outcomeLeast squares mean· Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks

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

GroupValue (percent of glycosylated hemoglobin)Spread
ILPS8.480.04
Glargine8.470.04
Secondary outcomeNumber· Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks

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

GroupValue (percent of participants)
ILPS46.9
Glargine50.7
Secondary outcomeMean· Baseline, Endpoint (LOCF) up to 24 weeks

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

GroupValue (milligrams per deciliter (mg/dL))Spread
ILPS175.4139.54
Glargine180.8638.95
Secondary outcomeMean· Baseline, Endpoint (LOCF) up to 24 weeks

Glycemic Variability at Baseline and Endpoint (LOCF)

GroupValue (mg/dL)Spread
ILPS41.1513.69
Glargine39.0213.52
Secondary outcomeNumber· Baseline to Endpoint (LOCF) up to 24 weeks

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

GroupValue (percentage of participants)
ILPS41.8
Glargine43.1
Secondary outcomeMean· Baseline to Endpoint (LOCF) up to 24 weeks

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

GroupValue (episodes/participant/365 days)Spread
ILPS14.5127.75
Glargine15.2929.73

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
ILPSInsulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks–9 / 17096 / 170
GlargineInsulin Glargine administered subcutaneously once a day at bedtime for 24 weeks–5 / 167115 / 167

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 74 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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