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Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus
This study is currently recruiting participants.
Verified by Amylin Pharmaceuticals, Inc., October 2008
Sponsors and Collaborators: Amylin Pharmaceuticals, Inc.
Eli Lilly and Company
Information provided by: Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00765817
  Purpose

This study will compare the efficacy and safety of exenatide versus placebo in adults whose diabetes is not fully controlled by insulin glargine with or without metformin and/or pioglitazone.


Condition Intervention Phase
Type 2 Diabetes
Drug: placebo
Drug: exenatide
Phase III

MedlinePlus related topics: Diabetes
Drug Information available for: Insulin Exenatide Insulin glargine Pioglitazone Pioglitazone hydrochloride Metformin Metformin hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized Trial Comparing Exenatide With Placebo in Subjects With Type 2 Diabetes on Insulin Glargine With or Without Oral Antihyperglycemic Medications

Further study details as provided by Amylin Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Test the hypothesis that twice daily exenatide plus titration of basal insulin is superior to placebo plus titration of basal insulin on glycemic control [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare the efficacy and safety of exenatide to placebo when added to basal insulin glargine with or without OAMs with respect to various pharmacodynamic measures. [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: October 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator Drug: placebo
subcutaneous injection, twice a day
2: Experimental Drug: exenatide
subcutaneous injection, twice a day, 10mcg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have type 2 diabetes.
  • Have been taking insulin glargine at a dose of ≥20 units/day for at least 3 months before entering the study.

Have been taking insulin glargine alone or in combination with one of the following for at least 3 months before entering the study:

  1. metformin (stable dose for 6 weeks)
  2. pioglitazone (stable dose for 6 weeks)
  3. a combination of metformin and pioglitazone (stable dose for 6 weeks)

    • Have HbA1C between 7.1% and 10.5%, inclusive.
    • Have a body mass index (BMI) ≤45 kg/m2.
    • Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).

Exclusion Criteria:

  • Have taken medications to lower blood sugar other than insulin glargine, pioglitazone, or metformin in the 3 months before entering the study for more than a 1-week period, or within 1 week of entering the study.
  • Have had more than one episode of major (severe) hypoglycemia in the 6 months before entering the study.
  • Are pregnant or intend to become pregnant during the study or are sexually active women not actively practicing birth control.
  • Women who are breastfeeding.
  • Have any significant diseases of the blood, heart, kidney, gastrointestinal system, or other significant diseases such as cancer.
  • Have had a kidney transplant or are currently on kidney dialysis.
  • Have a cancer that's never been treated, that's currently being treated, or that was diagnosed within the last 5 years.
  • Have had a bad reaction to exenatide in the past or have a condition that is not recommended to be exposed to exenatide or any of exenatide's other ingredients.
  • Have used a drug for weight loss in the 3 months before entering the study for more than a 1-week period, or within 1 month of entering the study.
  • Are currently on a weight-loss program or have been on one within 3 months of entering the study.
  • Have had a blood transfusion or severe blood loss within 3 months of entering the study.
  • Are taking systemic glucocorticoids or have received systemic glucocorticoids within 8 weeks of entering the study.
  • Have an irregular sleep cycle (for example, sleeping during the day and working during the night).
  • Have a history of pancreatitis.
  • Have received treatment with an experimental drug within 30 days of entering the study.
  • If on metformin, have a condition that is not recommended to be exposed to metformin, or any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis.
  • If on metformin, have had a radiologic contrast study performed within 48 hours of entering the study.
  • If on pioglitazone, have a condition that is not recommended to be exposed to pioglitazone, including congestive heart failure, or are taking pioglitazone at a dose that is not approved for use with insulin.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765817

Contacts
Contact: Lilly Clinical Trials Support Center 1-877-CTLILLY (1-877-285-4559)

  Show 43 Study Locations
Sponsors and Collaborators
Amylin Pharmaceuticals, Inc.
Eli Lilly and Company
Investigators
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
  More Information

Responsible Party: Eli Lilly and Company ( Study Director )
Study ID Numbers: H80-US-GWCO
Study First Received: October 1, 2008
Last Updated: October 24, 2008
ClinicalTrials.gov Identifier: NCT00765817  
Health Authority: United States: Food and Drug Administration;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   Greece: Ethics Committee;   Mexico: Ethics Committee;   Israel: Ministry of Health

Keywords provided by Amylin Pharmaceuticals, Inc.:
diabetes
exenatide
Amylin
Lilly
metformin
pioglitazone
insulin glargine

Study placed in the following topic categories:
Metabolic Diseases
Pioglitazone
Exenatide
Metformin
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009