Trial Outcomes & Findings for Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates (NCT NCT00609154)
NCT ID: NCT00609154
Last Updated: 2024-02-28
Results Overview
Blood insulin biosynthesis rate
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
24 hours
Results posted on
2024-02-28
Participant Flow
Recruitment of study participants across the range of 1999-041 studies occurred at the Albert Einstein College of Medicine beginning in November 2007. The first participant into 1999-041, Substudy #4 was enrolled during August 2010.
Of the 22 participants who provided informed consent for 1999-041 Substudy #4, 20 met inclusion/exclusion criteria and were enrolled and randomized into the study.
Participant milestones
| Measure |
Diabetic Group
Participants with Type 2 diabetes
glucagon like peptide-1: GLP-1 1 pmole/kg/min
glucose control: glucose without GLP-1
|
Non-diabetic Group
Participants 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
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
17
|
|
Overall Study
COMPLETED
|
2
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
8
|
Reasons for withdrawal
| Measure |
Diabetic Group
Participants with Type 2 diabetes
glucagon like peptide-1: GLP-1 1 pmole/kg/min
glucose control: glucose without GLP-1
|
Non-diabetic Group
Participants 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
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Unable to establish IV access
|
0
|
4
|
|
Overall Study
Adverse Event
|
0
|
2
|
Baseline Characteristics
Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates
Baseline characteristics by cohort
| Measure |
Diabetic Group
n=3 Participants
Participants with Type 2 diabetes
glucagon like peptide-1: GLP-1 1 pmole/kg/min
glucose control: glucose without GLP-1
|
Non-diabetic Group
n=17 Participants
Participants 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
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
20-29 years old
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Customized
30-39 years old
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Customized
40-49 years old
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Customized
50-59 years old
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, Not Hispanic
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
17 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Study was terminated early. The LC/MS assay being developed to optimize and validate the analysis of insulin and proinsulin biosynthesis samples was never completed and, as such, data were not collected.
Blood insulin biosynthesis rate
Outcome measures
Outcome data not reported
Adverse Events
Diabetic Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-diabetic Group
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diabetic Group
n=3 participants at risk
Participants with Type 2 diabetes
glucagon like peptide-1: GLP-1 1 pmole/kg/min
glucose control: glucose without GLP-1
|
Non-diabetic Group
n=17 participants at risk
Participants 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
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp (transient)
|
0.00%
0/3 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
5.9%
1/17 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
5.9%
1/17 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/3 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
5.9%
1/17 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
|
Vascular disorders
Superficial Thrombophlebitis
|
0.00%
0/3 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
5.9%
1/17 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
29.4%
5/17 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
23.5%
4/17 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
|
General disorders
Fever
|
0.00%
0/3 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
5.9%
1/17 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
5.9%
1/17 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/3 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
5.9%
1/17 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
5.9%
1/17 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
|
General disorders
Edema Limbs
|
0.00%
0/3 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
5.9%
1/17 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
|
General disorders
Injection Site Reaction
|
0.00%
0/3 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
5.9%
1/17 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
5.9%
1/17 • Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place