Prediabetic State
Conditions
Keywords
Prediabetic State
Brief summary
To determine whether treatment with the diabetes medication, Januvia (sitagliptin), with or without another diabetes medicine, Actos (pioglitazone), will improve insulin secretion and insulin response individuals with Impaired Glucose Tolerance (IGT), a form of prediabetes.
Interventions
DRUGSitagliptin + Pioglitazone PLACEBO
Sitagliptin 100 mg tablet daily + Pioglitazone PLACEBO 15 mg capsule daily
DRUGSitagliptin + Pioglitazone
Sitagliptin 100 mg tablet daily + Pioglitazone 15 mg capsule daily
DRUGPLACEBO
Sitagliptin placebo 100 mg tablet daily + Pioglitazone placebo 15 mg capsule daily
Sponsors
Merck Sharp & Dohme LLC
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Impaired glucose tolerance (IGT) by oral glucose tolerance test
Exclusion criteria
* History of diabetes mellitus * History of congestive heart failure * History of coronary artery disease or other macrovascular disease (stroke, peripheral vascular disease) * History of liver disease (ALT or AST \>2.5 times the upper limit of normals) * History of renal disease (serum creatinine \>1.5 mg/dl) * History of severe osteoporosis (frequent fractures, failure on osteoporosis treatment) * Current treatment with glucocorticoids * History of immune disorder, including HIV * Women of child-bearing age who are pregnant, desire to become pregnant, are breastfeeding, or who refuse to take the recommended birth control measures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Secretion | baseline, 6 months, 9 months (after a 3 month washout) | Not measured as study was prematurely terminated due to unanticipated delays. |
Countries
United States
Participant flow
Recruitment details
Only 3 control (normal glucose tolerance) subjects were enrolled to obtain results in normal subjects for the hyperglycemic clamp (without GLP-1 or arginine). No samples were run, and, therefore, there are no data for the control subjects. No subjects with impaired glucose tolerance (IGT) were recruited or enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Sitagliptin + Pioglitazone PLACEBO Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth
\+ pioglitazone PLACEBO daily by mouth | 0 |
| Sitagliptin + Pioglitazone Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth
\+ pioglitazone (TZD) 15 mg daily by mouth | 0 |
| PLACEBO Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth
\+ pioglitazone (TZD) PLACEBO daily by mouth | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Sex: Female, Male Female | — Participants |
| Sex: Female, Male Male | — Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Insulin Secretion
Not measured as study was prematurely terminated due to unanticipated delays.
Time frame: baseline, 6 months, 9 months (after a 3 month washout)