A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes - Full Text View

Sponsor:	Amylin Pharmaceuticals, Inc.
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00467649

Purpose

This will be a randomized, open label, parallel group, multicenter study. There will be two phases in the study. Phase 1 (Baseline to Week 24) will compare the efficacy and safety of regimens of basal insulin intensified with either Symlin or rapid acting insulin in patients with type 2 diabetes who have either been on a prior regimen of insulin for less than 6 months and were taking less than 50 U total of insulin per day OR are candidates for the initiation of insulin therapy. The purpose of Phase 2 (Week 24 to Week 36) is to explore further intensification of diabetes regimens in patients failing to achieve HbA1c <=6.5% at Week 24.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: pramlintide acetate Drug: rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]) Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 4, Randomized, Open Label, Parallel Group, Multicenter Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Hypoglycemia

Drug Information available for: Insulin Insulin aspart Insulin lispro Pramlintide Insulin glargine Insulin Detemir Pramlintide acetate Insulin glulisine

U.S. FDA Resources

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

Primary Outcome Measures:

The Proportion of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of Patients Achieving HbA1c <=7% at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Proportion of Patients With no Weight Gain at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Proportion of Patients With a Severe Hypoglycemia Adverse Event [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Change in HbA1c From Baseline at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Change in Body Weight From Baseline at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Change in Waist Circumference From Baseline [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Change in Fasting Plasma Glucose From Baseline [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Fasting Serum Lipids Change From Baseline at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Phase 2: Change in HbA1c at Week 36 [ Time Frame: 36 Weeks ] [ Designated as safety issue: No ]
Phase 2: Change in Body Weight at Week 36 [ Time Frame: 36 Weeks ] [ Designated as safety issue: No ]

Enrollment:	113
Study Start Date:	April 2007
Study Completion Date:	May 2008

Arms	Assigned Interventions
Group A: Experimental	Drug: pramlintide acetate subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir]) subcutaneous injection, dosing based on titration guidelines
Group B: Active Comparator	Drug: rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]) subcutaneous injection, dosing based on titration guidelines Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir]) subcutaneous injection, dosing based on titration guidelines

Eligibility

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

Criteria

Inclusion Criteria:

Has a clinical diagnosis of type 2 diabetes mellitus
Has an HbA1c >7.0% and ≤10.0%
Has a BMI of ≥25 kg/m^2 and ≤50 kg/m^2
Has been on a regimen of insulin for less than 6 months and is taking less than 50 U total of insulin per day, OR has not been on a pre existing insulin regimen and is a candidate for the initiation of basal insulin therapy

Exclusion Criteria:

Has experienced recurrent severe hypoglycemia requiring assistance during the past 6 months
Requires the use of drugs that stimulate gastrointestinal motility
Has been previously treated with Symlin (or has participated in a Symlin clinical study)
Is currently being treated with any of the following medications: *Over-the-counter antiobesity agents (including, but not limited to, herbal supplements) or prescription antiobesity agents (including orlistat [Xenical®] and sibutramine [Meridia®]); *Oral, intravenous, or intramuscular systemic steroids by oral or potent inhaled or intrapulmonary steroids that are known to have a high rate of systemic absorption; *Drugs that directly affect gastrointestinal motility, including but not limited to: dopamine antagonists (e.g., metoclopramide [Reglan®]), opiates or anticholinergics; and chronic (more than 10 days within a 6-month period) macrolide antibiotics such as erythromycin and newer derivatives; *Investigational medications
Has a history or presence of any of the following: *Eating disorders (including anorexia and/or bulimia); *Bariatric surgery (gastric bypass, gastric banding, or gastroplasty)
Is currently enrolled in a weight-loss program or plans to enroll in a weight-loss program before termination of the study
Has donated blood within 30 days of study start or plans to donate blood during the duration of the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467649

Show 37 Study Locations

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

Investigators

Study Director:

Lisa Porter, MD

Amylin Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Amylin Pharmaceuticals ( Lisa Porter, MD, Study Director )
Study ID Numbers:	ACA401
Study First Received:	April 27, 2007
Results First Received:	April 10, 2009
Last Updated:	April 10, 2009
ClinicalTrials.gov Identifier:	NCT00467649 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Amylin Pharmaceuticals, Inc.:

Symlin
Amylin
insulin

Humalog
Novolog
Apidra

Additional relevant MeSH terms:

Metabolic Diseases
Insulin glulisine
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Insulin LISPRO
Pharmacologic Actions

Insulin
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Glargine
Pramlintide
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on March 18, 2010