Trial intelligence / Profile preview

Symlin added to Lantus in Type 2 Diabetes

NCT00240253Phase 4

Key facts

Status: Completed
Start: Oct 2005
Primary completion: Jun 2006
Countries: 1
Sponsor: AstraZeneca
Modality: Peptides

Drugs: pramlintide
Conditions: type 2 diabetes mellitus (T2DM)

Overview

Phase 4, randomised, double-blind trial in type 2 diabetes mellitus (T2DM) comparing Pramlintide + Insulin Glargine with Placebo + Insulin Glargine (2 arms). Primary endpoint: Efficacy and Safety at 16 weeks. Started Oct 2005; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Pramlintide + Insulin Glargine
Symlin added to established insulin glargine regimen
Placebo + Insulin Glargine
Placebo added to established insulin glargine regimen

Endpoints

Primary

Efficacy and Safety16 weeks

Secondary

Markers of cardiovascular risk16 weeks
Fasting serum lipids16 weeks
Fasting plasma glucose16 weeks
Waist circumference16 weeks
Patient-reported outcomes16 weeks

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