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

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:

MedlinePlus related topics: Diabetes Type 2

Drug Information available for: Insulin Insulin human Pramlintide Insulin glargine Pramlintide acetate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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. [ Time Frame: 16 Weeks ]

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. [ Time Frame: 16 Weeks ]


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

Arms	Assigned Interventions
Active Comparator: Pramlintide	Drug: pramlintide acetate Clear, colorless, sterile solution for SC injection

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
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

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: NCT00240253

Show 34 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators


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

More Information

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

Peyrot M, Rubin RR, Polonsky WH. Diabetes distress and its association with clinical outcomes in patients with type 2 diabetes treated with pramlintide as an adjunct to insulin therapy. Diabetes Technol Ther. 2008 Dec;10(6):461-6. doi: 10.1089/dia.2008.0031.

Wysham C, Lush C, Zhang B, Maier H, Wilhelm K. Effect of pramlintide as an adjunct to basal insulin on markers of cardiovascular risk in patients with type 2 diabetes. Curr Med Res Opin. 2008 Jan;24(1):79-85.

Riddle M, Frias J, Zhang B, Maier H, Brown C, Lutz K, Kolterman O. Pramlintide improved glycemic control and reduced weight in patients with type 2 diabetes using basal insulin. Diabetes Care. 2007 Nov;30(11):2794-9. Epub 2007 Aug 13.


Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00240253 History of Changes
Other Study ID Numbers:	137-156
Study First Received:	October 14, 2005
Last Updated:	March 26, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:


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 Insulin Insulin Glargine	Islet Amyloid Polypeptide Hypoglycemic Agents Physiological Effects of Drugs Appetite Depressants Anti-Obesity Agents Amylin Receptor Agonists Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 23, 2016