Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes - Full Text View

Purpose

This open label study is designed to assess long term glucose control, as measured by hemoglobin A1c (HbA1c) and to evaluate long term safety and tolerability in subjects with type 2 diabetes mellitus who receive subcutaneously injected exenatide administered twice a day.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: exenatide	Phase 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open Label Study to Examine the Long Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Type 2

Drug Information available for: Exenatide

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change in HbA1c (glycosylated hemoglobin) from Visit 1 to each protocol visit [ Time Frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) ] [ Designated as safety issue: No ]
Change in HbA1c from Visit 1 to each visit up to open-ended study termination
Change in body weight from Visit 1 to each protocol visit [ Time Frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) ] [ Designated as safety issue: No ]
Change in body weight (kg) from Visit 1 to each visit up to open-ended study termination
Change in fasting plasma glucose from Visit 1 to each protocol visit [ Time Frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) ] [ Designated as safety issue: No ]
Change in fasting plasma glucose from Visit 1 to each visit up to open-ended study termination
Change in lipids from Visit 1 to each protocol visit [ Time Frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) ] [ Designated as safety issue: No ]
Change in lipids from Visit 1 to each visit up to open-ended study termination


Enrollment:	456
Study Start Date:	November 2002
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Exenatide Exenatide 5 mcg for 4 weeks (transition) then 10 mcg to study termination	Drug: exenatide subcutaneous injection, 5 mcg, twice a day for 4 weeks (transition period), then 10 mcg twice a day till study termination Other Names: Byetta exendin-4 AC2993

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The subject has an HbA1c value <=11.0%
The subject has a body mass index (BMI) of 25 kg/m^2 to 45 kg/m^2, inclusive

Exclusion Criteria:

Is currently treated with certain medications, including exogenous insulin

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111540

Show 60 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	Lisa Porter, MD	Amylin Pharmaceuticals, LLC.

More Information

Publications:

Blonde L, Klein EJ, Han J, Zhang B, Mac SM, Poon TH, Taylor KL, Trautmann ME, Kim DD, Kendall DM. Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes. Diabetes Obes Metab. 2006 Jul;8(4):436-47.

Buse JB, Klonoff DC, Nielsen LL, Guan X, Bowlus CL, Holcombe JH, Maggs DG, Wintle ME. Metabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: an interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials. Clin Ther. 2007 Jan;29(1):139-53.

Klonoff DC, Buse JB, Nielsen LL, Guan X, Bowlus CL, Holcombe JH, Wintle ME, Maggs DG. Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years. Curr Med Res Opin. 2008 Jan;24(1):275-86.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.

Nelson P, Poon T, Guan X, Schnabel C, Wintle M, Fineman M. The incretin mimetic exenatide as a monotherapy in patients with type 2 diabetes. Diabetes Technol Ther. 2007 Aug;9(4):317-26.


Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00111540 History of Changes
Other Study ID Numbers:	2993-119
Study First Received:	May 23, 2005
Last Updated:	February 19, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:


exenatide diabetes Amylin exendin-4

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Exenatide	Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 30, 2016