Trial Outcomes & Findings for Role of Exenatide in Type 1 Diabetes (NCT NCT00456300)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

0-120 minutes post-dose

Results posted on

2019-02-26

Participant Flow

11 subjects were enrolled into the study. Of these, 9 subjects were randomized and only 8 subjects completed this three part study. These subjects were recruited from the diabetes clinics.

Two subjects failed screening and could not be randomized to particiapate.

Participant milestones

Participant milestones
Measure	Insulin First, Then Exenatide1.25 mcg, Then Exenatide 2.5 mcg Each of the eight study subjects underwent three study visits at-least 3 weeks apart; at each visit receiving either Insulin alone, Exenatide 1.25 mcg + Insulin or Exenatide 2.5 mcg + Insulin	Insulin First, Then Exenatide 2.5 mcg, Then Exenatide 1.25 mcg Each of the eight study subjects underwent three study visits at-least 3 weeks apart; at each visit receiving either Insulin alone, Exenatide 2.5 mcg + Insulin or Exenatide 1.25 mcg + Insulin
Overall Study STARTED	5	4
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Insulin First, Then Exenatide1.25 mcg, Then Exenatide 2.5 mcg Each of the eight study subjects underwent three study visits at-least 3 weeks apart; at each visit receiving either Insulin alone, Exenatide 1.25 mcg + Insulin or Exenatide 2.5 mcg + Insulin	Insulin First, Then Exenatide 2.5 mcg, Then Exenatide 1.25 mcg Each of the eight study subjects underwent three study visits at-least 3 weeks apart; at each visit receiving either Insulin alone, Exenatide 2.5 mcg + Insulin or Exenatide 1.25 mcg + Insulin
Overall Study Adverse Event	1	0

Baseline Characteristics

Role of Exenatide in Type 1 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=9 Participants Following the baseline study with insulin, Participants were randomized to receive either Exenatide 1.25 mcg or Exenatide 2.5 mcg
Age, Continuous	17 years STANDARD_DEVIATION 1 • n=99 Participants
Sex: Female, Male Female	4 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Region of Enrollment United States	9 participants n=99 Participants

PRIMARY outcome

Timeframe: 0-120 minutes post-dose

Population: All participants who received at least one dose of each intervention and completed all study visits were included in the analyses. Only 8 subjects completed all study visits and one dropped out during the second study visit.

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

Outcome measures

Outcome measures
Measure	Exenatide 1.25 mcg + Insulin n=8 Participants Participants who received Exenatide 1.25 mcg along with Insulin as a single subcutaneous injection	Exenatide 2.5 mcg + Insulin n=8 Participants Participants who received Exenatide 2.5 mcg along with Insulin as a single subcutaneous injection	Insulin Monotherapy n=8 Participants Participants who received Insulin alone as a single subcutaneous injection, part of baseline study
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	49 mmol*L/min Standard Error 156	44 mmol*L/min Standard Error 281	379 mmol*L/min Standard Error 259

Adverse Events

Exenatide 1.25 mcg + Insulin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Exenatide 2.5 mcg + Insulin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Insulin Monotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Exenatide 1.25 mcg + Insulin n=9 participants at risk Participants who received Exenatide 1.25 mcg along with Insulin as a single subcutaneous injection	Exenatide 2.5 mcg + Insulin n=9 participants at risk Participants who received Exenatide 2.5 mcg along with Insulin as a single subcutaneous injection	Insulin Monotherapy n=9 participants at risk Participants who received Insulin alone as a single subcutaneous injection, as part of the baseline study visit
Endocrine disorders Hypoglycemia	11.1% 1/9 • Number of events 1 • 0-120 minutes post-dose	0.00% 0/9 • 0-120 minutes post-dose	0.00% 0/9 • 0-120 minutes post-dose

Additional Information

Rubina Heptulla

Montefiore Medical College

Phone: 832824000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place