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

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: pramlintide acetate (Symlin); Drug: rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]); Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])

Study type: Interventional

Funder types: Industry

Identifiers

NCT00467649

ACA401

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Group A

Experimental group

Treatment:

Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])

Drug: pramlintide acetate (Symlin)

Group B

Active Comparator group

Treatment:

Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])

Drug: rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])