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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group A
Intervention: pramlintide acetate (Symlin) (Drug)
Group A
Intervention: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir]) (Drug)
Group B
Intervention: rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]) (Drug)
Group B
Intervention: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir]) (Drug)
Outcomes
Primary Outcomes
The Percentage 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
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 Outcomes
- Percentage of Patients Achieving HbA1c <=7% at Week 24(24 Weeks)
- Percentage of Patients With a Severe Hypoglycemia Adverse Event(24 Weeks)
- Change in Waist Circumference From Baseline at Week 24(From Baseline to Week 24)
- Phase 2: Change in HbA1c at Week 36(Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36)
- Change in HbA1c From Baseline at Week 24(From Baseline to Week 24)
- Change in Body Weight From Baseline at Week 24(From Baseline to Week 24)
- Fasting Serum Lipids Change From Baseline to Week 24(Baseline, week 24)
- Percentage of Patients With no Weight Gain at Week 24(24 Weeks)
- Change in Fasting Plasma Glucose From Baseline at Week 24(From Baseline to Week 24)
- Phase 2: Change in Body Weight at Week 36(Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36)