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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:
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00240253
First received: October 14, 2005
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

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

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

  Show 34 Study Locations
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Investigators
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
  More Information

No publications provided by Amylin Pharmaceuticals, LLC.

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: February 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, LLC.:
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 June 18, 2013