Trial · Interventional

CompletedPhase 2Results postedRegistry data

Role of Exenatide in Type 1 Diabetes

NCTNCT00456300Other idH-16488

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 11 participants (actual)
Sponsor: Montefiore Medical Center · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: Mar 2007
Primary completion: Mar 2009
Completion: Mar 2009
First posted: 4 Apr 2007 (estimated)
Last update posted: 26 Feb 2019
Conditions: Type 1 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

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

2007200820092010

Ph 2
Role of Exenatide in Type 1 Diabetes
NCT00456300
Mar 2007 to Mar 2009

Registry summary

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

The purpose of this study is to see if giving exenatide and insulin before a meal would lower blood sugars after the meal. This study may help in developing new treatments to help control high blood sugars after meals. This may help improve overall blood sugar control and prevent the long-term effects of diabetes.

Interventions

ExenatideDrug
InsulinDrug

Arms3

Experimental
Exenatide 1.25 mcg + Insulin
In each intervention arm the participant receives a different dose of Exenatide along with Insulin as a single subcutaneous injection
Experimental
Exenatide 2.5 mcg + Insulin
In each intervention arm the participant receives a different dose of Exenatide along with Insulin as a single subcutaneous injection
Active comparator
Insulin
Each subject received a baseline study with insulin alone

Primary outcomes1

Outcomes the sponsor listed as primary.

Mean Plasma Glucose Area Under the Curve (AUC) for Blood Glucose Concentration in the Exenatide 1.25 mcg or Exenatide 2.5 mcg Treated Groups Along With Insulin, Compared to Insulin Alone
Time frame · 0-120 minutes post-dose
Registry description
Post-prandial blood glucose concentration in terms of mean AUC (0-120 min) was determined in subjects treated with either Exenatide 1.25 mcg or Exenatide 2.5 along with insulin, compared to insulin alone, given as a single subcutaneous injection

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 outcomeMean· 0-120 minutes post-dose

Mean Plasma Glucose Area Under the Curve (AUC) for Blood Glucose Concentration in the Exenatide 1.25 mcg or Exenatide 2.5 mcg Treated Groups Along With Insulin, Compared to Insulin Alone

Group	Value (mmol*L/min)	Spread
Exenatide 1.25 mcg + Insulin	49	156
Exenatide 2.5 mcg + Insulin	44	281
Insulin Monotherapy	379	259

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Exenatide 1.25 mcg + InsulinParticipants who received Exenatide 1.25 mcg along with Insulin as a single subcutaneous injection	0 / 9	0 / 9	1 / 9
Exenatide 2.5 mcg + InsulinParticipants who received Exenatide 2.5 mcg along with Insulin as a single subcutaneous injection	0 / 9	0 / 9	0 / 9
Insulin MonotherapyParticipants who received Insulin alone as a single subcutaneous injection, as part of the baseline study visit	0 / 9	0 / 9	0 / 9

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2010

3 results

The role of adjunctive exenatide therapy in pediatric type 1 diabetes.

Raman et al. 2010Diabetes carecited by 64

PMID 20332358PMC2875441DOI 10.2337/dc09-1959PUB-20332358

Free to read · publisher termsCC BY-NC-ND3 results

Read at source See results (3)

Eligibility

Who could join, as posted.

Sex: All
Age: from 12 Years up to 21 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: \*\*\*Subjects must be patients of the Texas Children's Hospital Diabetes Care Center\*\*\*. All of the following criteria must be met: 1. Between 12-21 years of age at the time of enrollment. 2. Have been diagnosed with Type 1 diabetes for at least 1 year and in good control (HbA1C less than 8.5%). 3. Subjects must be otherwise healthy except for the Type 1 Diabetes and treated hypothyroidism. 4. Menstruating women must have a negative pregnancy test. 5. Hemoglobin equal to or greater than 12 g/dL before each study. 6. Weight greater than 44 kg. 7. Tanner stage greater than 3 Exclusion Criteria: 1. Any chronic disease: leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis etc or on treatment that might directly or indirectly affect glucose homeostasis, except for diabetes and hypothyroidism; stable on medications. 2. Lack of a supportive family environment as detected by the clinicians and/or social workers. 3. Positive pregnancy test in menstruating young women. 4. BMI greater than 90th percentile for age or less than 10th percentile for age. 5. Lactating and nursing mothers.

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