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

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: pramlintide acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00240253

137-156

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 1 patient group

Pramlintide

Active Comparator group

Treatment:

Drug: pramlintide acetate