A Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00240253
First received: October 14, 2005
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes who are not achieving glycemic targets.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: pramlintide acetate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes Who Are Not Achieving Glycemic Targets

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes.

Secondary Outcome Measures:
  • To evaluate the effects of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes on markers of cardiovascular risk, fasting serum lipids, fasting plasma glucose, waist circumference, and patient-reported outcomes.

Estimated Enrollment: 200
Study Start Date: October 2005
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has HbA1c >7.0% and <=10.5%
  • Has a body mass index (BMI) >=25 kg/m2 and <=45 kg/m2
  • Has received insulin glargine for 3 months prior to study start and has been on a stable dose for 1 month prior to study start
  • If taking oral antidiabetic agents, has been on a stable dose for at least 2 months

Exclusion Criteria:

  • Has been previously treated with Symlin/pramlintide (or has participated in a Symlin/pramlintide clinical study)
  • Has received any investigational drug within 1 month of screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00240253

  Hide Study Locations
Locations
United States, Arizona
Research Site
Phoenix, Arizona, United States
United States, California
Research Site
Concord, California, United States
Research Site
La Jolla, California, United States
Research Site
Los Gatos, California, United States
Research Site
Salinas, California, United States
Research Site
Walnut Creek, California, United States
United States, Colorado
Research Site
Denver, Colorado, United States
United States, Connecticut
Research Site
New Britain, Connecticut, United States
United States, District of Columbia
Research Site
Washington, District of Columbia, United States
United States, Florida
Research Site
Palm Harbor, Florida, United States
United States, Georgia
Research Site
Atlanta, Georgia, United States
United States, Indiana
Research Site
Indianapolis, Indiana, United States
United States, Kansas
Research Site
Wichita, Kansas, United States
United States, Kentucky
Research Site
Lexington, Kentucky, United States
United States, Louisiana
Research Site
Baton Rouge, Louisiana, United States
United States, Michigan
Research Site
Bloomfield Hills, Michigan, United States
Research Site
Detroit, Michigan, United States
Research Site
Grand Rapids, Michigan, United States
United States, Missouri
Research Site
Chesterfield, Missouri, United States
United States, Montana
Research Site
Butte, Montana, United States
United States, Nebraska
Research Site
Omaha, Nebraska, United States
United States, North Carolina
Research Site
Charlotte, North Carolina, United States
Research Site
Durham, North Carolina, United States
United States, Ohio
Research Site
Cincinnati, Ohio, United States
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
United States, Oregon
Research Site
Medford, Oregon, United States
Research Site
Portland, Oregon, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Tipton, Pennsylvania, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
United States, Texas
Research Site
Dallas, Texas, United States
United States, Virginia
Research Site
Charlottesville, Virginia, United States
United States, Washington
Research Site
Olympia, Washington, United States
Research Site
Spokane, Washington, United States
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
  More Information

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00240253     History of Changes
Other Study ID Numbers: 137-156
Study First Received: October 14, 2005
Last Updated: September 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
diabetes
Amylin
Symlin
pramlintide
insulin glargine

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pramlintide
Glargine
Insulin
Insulin, Long-Acting
Islet Amyloid Polypeptide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014