Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia

NCT01269047 · Completed

Last updated 2026-05-28

This clinical trial tested whether the medications exenatide and pramlintide, when added to insulin, could help control blood sugar spikes after meals in people with type 1 diabetes.

Status Completed The study has finished.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 37 people

Who can join Ages 12–21 · all sexes

Timeline Started 2009-08 · est. completion 2016-12

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT01269047 ↗

Description as written by the study sponsor.

The main purpose of the study is to determine the effects of 16 weeks of adjunctive pramlintide or exenatide use on glycemic control in Type 1 Diabetes.

Treatments tested

Pramlintide also known as Symlin Drug

Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months
Exenatide also known as Byetta, Type 1 diabetes Drug

Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months
Insulin also known as Novolog, Humalog, Levemir, Lantus Drug

Rapid acting and long acting, subcutaneously, according to their regimen for the entire duration of the study.

Main thing measured	Post-prandial Blood Glucose Concentration in Both Pramlintide and Exenatide Treated Groups in Acute and Chronic Setting, Compared to Insulin Monotherapy in Type 1 Diabetes Mellitus.
Sponsor	Albert Einstein College of Medicine
Conditions studied	Type 1 Diabetes
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01269047 ↗