A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])Drug: pramlintide acetate (Symlin)Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
- Registration Number
- NCT00467649
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]) - Group B basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir]) - Group A basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir]) - Group A pramlintide acetate (Symlin) -
- Primary Outcome Measures
Name Time Method The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia 24 Weeks A severe hypoglycemia is defined as an event during which the patient required the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention.
- Secondary Outcome Measures
Name Time Method Percentage of Patients Achieving HbA1c <=7% at Week 24 24 Weeks This is a component of the primary endpoint
Percentage of Patients With a Severe Hypoglycemia Adverse Event 24 Weeks This is a component of the primary endpoint.
Change in Waist Circumference From Baseline at Week 24 From Baseline to Week 24 Baseline values are presented in the Baseline Characteristics section
Phase 2: Change in HbA1c at Week 36 Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36 Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only).
Change in HbA1c From Baseline at Week 24 From Baseline to Week 24 Baseline values are presented in the Baseline Characteristics section
Change in Body Weight From Baseline at Week 24 From Baseline to Week 24 Baseline values are presented in the Baseline Characteristics section
Fasting Serum Lipids Change From Baseline to Week 24 Baseline, week 24 Percentage of Patients With no Weight Gain at Week 24 24 Weeks This is a component of the primary endpoint
Change in Fasting Plasma Glucose From Baseline at Week 24 From Baseline to Week 24 Baseline values are presented in the Baseline Characteristics section
Phase 2: Change in Body Weight at Week 36 Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36 Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only).
Trial Locations
- Locations (1)
Research Site
🇺🇸Spokane, Washington, United States