Phase 4
N=22
Incretins in Impaired Fasting Glucose
Pre-diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00364377 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: Lowering of Fasting Glucose — 5.78; 5.83 mmol/l — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sitagliptin (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lowering of Fasting Glucose |
5.78; 5.83 | >0.05 |
Summary
People with high fasting glucose can develop type 2 diabetes with the passage of time. This study is being done to determine the effect of a novel medication in people with this elevated fasting glucose. Sitagliptin is a substance that raises levels of a hormone normally found in the blood. This hormone, called glucagon-like peptide-1 (GLP-1), is normally released by the intestine in response to the presence of food. This hormone acts like a messenger between the intestine and the pancreas to raise insulin levels, and therefore, lower blood sugars. Sitagliptin is effective in people with diabetes, however, this study is being done to determine if Sitagliptin is effective in people with high fasting glucose who do not yet have diabetes.
Eligibility Criteria
Twenty four participants aged 35 to 70 years with impaired fasting glucose (100mg/dl-125 mg/dl) will be studied.
Inclusion Criteria
- Males and females between the ages of 35-70.
- Good health as determined by past medical history,physical examination, vital signs, electrocardiogram and laboratory tests at the time of screening.
- Patients on diuretics or thyroid hormone therapy must be on a stable dose (at least 3 months prior to screening) and the maintenance dose may not be adjusted during the study.
Exclusion Criteria
- Individuals with a body mass index less than 19 or greater than 40 kg/m^2, or a total weight > 130 kg, will be excluded from study.
- Subjects less than 35 years will not be studied in order to minimize the possibility of studying subjects with type 1 diabetes.
- No history of a) significant nephropathy, (i.e., plasma creatinine > 1.4 mg/dl in women and 1.5 mg/dl in men, and/or proteinuria); b) clinically significant atherosclerotic vascular disease (e.g., history of heart attack or angina); c) a known systemic illness.
- Pregnant or lactating females.
Data sourced from ClinicalTrials.gov (NCT00364377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.