Type 2 Diabetes
Conditions
Keywords
Type 2 diabetes, Insulin, biosynthesis, Non diabetic control
Brief summary
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.
Detailed description
We will measure the rate of new insulin production in subjects with Type 2 diabetes compared to non diabetic subjects. We hypothesize that subjects with Type 2 diabetes make less insulin in response to GLP-1 compared to non diabetic subjects.
Interventions
GLP-1 1 pmole/kg/min
DIETARY_SUPPLEMENTglucose control
glucose without GLP-1
Sponsors
Merck Sharp & Dohme LLC
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Biosynthesis Rate | 24 hours | Blood insulin biosynthesis rate |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Diabetic Group Participants with Type 2 diabetes
glucagon like peptide-1: GLP-1 1 pmole/kg/min
glucose control: glucose without GLP-1 | 3 |
| 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 | 17 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | Unable to establish IV access | 0 | 4 |
Baseline characteristics
| Characteristic | Diabetic Group | Non-diabetic Group | Total |
|---|---|---|---|
| Age, Customized 20-29 years old | 0 Participants | 3 Participants | 3 Participants |
| Age, Customized 30-39 years old | 0 Participants | 5 Participants | 5 Participants |
| Age, Customized 40-49 years old | 3 Participants | 5 Participants | 8 Participants |
| Age, Customized 50-59 years old | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 7 Participants | 9 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized Multiracial | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White, Not Hispanic | 0 Participants | 4 Participants | 4 Participants |
| Region of Enrollment United States | 3 participants | 17 participants | 20 participants |
| Sex: Female, Male Female | 2 Participants | 7 Participants | 9 Participants |
| Sex: Female, Male Male | 1 Participants | 10 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 17 |
| other Total, other adverse events | 0 / 3 | 7 / 17 |
| serious Total, serious adverse events | 0 / 3 | 0 / 17 |
Outcome results
Primary
Insulin Biosynthesis Rate
Blood insulin biosynthesis rate
Time frame: 24 hours
Population: 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.