Trial · Interventional

TerminatedPhase 1/2Results postedRegistry data

Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates

NCTNCT00609154Other id1999-041, Sub-study #4Other idSub-study 4Other idR01DK061644-09

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Per source documents the study was terminated well in advance of targeted enrollment. A method for the analysis of insulin and proinsulin samples was never fully developed and validated. Study terminated upon expiration of IRB approval

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 1/2
Enrollment: 20 participants (actual)
Sponsor: Albert Einstein College of Medicine · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 12 Aug 2010
Primary completion: 13 May 2014
Completion: 13 May 2014
First posted: 6 Feb 2008 (estimated)
Last update posted: 28 Feb 2024
Conditions: Type 2 Diabetes

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201020112012201320142015

Ph 1/2
Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates
NCT00609154
12 Aug 2010 to 13 May 2014
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The gut hormone glucagon like peptide-1 (GLP-1) has been shown to have important effects on maintaining the function and health of the insulin producing beta cells. This hormone is known to increase the production rate of new insulin as well as increase the release of insulin into the blood.

Interventions

glucagon like peptide-1Drug
glucose controlDietary supplement

Arms2

Experimental
Diabetic Group
Participants with Type 2 diabetes
Active comparator
Non-diabetic Group
Participants who are non-diabetic will serve as control. treatment is matched to experimental group

Primary outcomes1

Outcomes the sponsor listed as primary.

Insulin Biosynthesis Rate
Time frame · 24 hours
Registry description
Blood insulin biosynthesis rate

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· 24 hours

Insulin Biosynthesis Rate

Group	Value
Diabetic Group	not posted
Non-diabetic Group	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Diabetic GroupParticipants with Type 2 diabetes glucagon like peptide-1: GLP-1 1 pmole/kg/min glucose control: glucose without GLP-1	0 / 3	0 / 3	0 / 3
Non-diabetic GroupParticipants who are non-diabetic will serve as control. treatment is matched to experimental group glucagon like peptide-1: GLP-1 1 pmole/kg/min glucose control: glucose without GLP-1	0 / 17	0 / 17	7 / 17

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 65 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Type 2 Diabetes * Non diabetic Exclusion Criteria: * Currently taking medication such as thiazolidinediones, metformin, Exenatide, or sitagliptin * Chronic condition such as chronic heart failure CHF), Coronary Artery Disease (CAD), or chronic renal failure (CRF) * Anemia

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