Type 2 Diabetes mellitus MedDRA version: 8.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient has T2DM. 2. Patient is a male or female and =18 years of age on day of signing informed consent. 3. Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and post-study follow-up period. 4. Patient is a male, or is a female who is highly unlikely to conceive, as indicated by at least one “yes” answer to the following questions: a. Patient is a male. b. Patient is a surgically sterilized female. c. Patient is a postmenopausal female =45 years of age with >2 years since last menses. d. Patient is a non-sterilized premenopausal female and (if sexually active) agrees to use 2 adequate methods of contraception to prevent pregnancy (either 2 barrier methods or a barrier method plus a hormonal contraceptive method) and for 14 days after the last dose of study medication.Note: Acceptable methods of birth control are: hormonal contraceptive, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, or vasectomy. 5. Patient understands the study procedures and agrees to participate in the study by giving written informed consent. Glycemic Entry Criteria 6. Patient has not been on any oral antihyperglycemic medication or insulin therapy prior to screening (except as described below and in Section 2.3) and has a Visit 1/ Screening Visit 1 HbA1c =8.0% and =12.0%. Note: Patients may participate who have =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Glucose Metabolism and Therapy Criteria 1. Patient has a history of type 1 diabetes mellitus or history of ketoacidosis. 2. Patient was on antihyperglycemic agent therapy (oral or insulin) within 4 months prior to screening. 3. Patient was on > 4 weeks (cumulatively) of antihyperglycemic therapy over the prior 2 years. 4. Patient has symptomatic hyperglycemia which the investigator assesses as requiring immediate initiation of antihyperglycemic therapy (i.e., without 2 week diet and exercise run-in period). Patients Requiring Specific Treatments 5. Patient is on a weight loss program and is not in the maintenance phase or has started on a weight loss medication (e.g. orlistat or sibutramine) within the prior 8 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objective: After 24 weeks, to assess the effect of the coadministration of sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. compared to pioglitazone alone on HbA1c. Objective: To assess the safety and tolerability of the coadministration of sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d.;Secondary Objective: In patients with T2DM with inadequate glycemic control: Objective: After 24 weeks, to assess the effect of the coadministration of sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. compared to pioglitazone 30 mg q.d. alone on the 2-hour post prandial glucose (PPG) following a standard meal challenge. Objective: After 24 weeks, to assess the effect of the coadministration of sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. compared to pioglitazone 30 mg q.d. alone on FPG. Objective: After 1 week, to assess the effect of the coadministration of sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. compared to pioglitazone 30 mg q.d. alone on FPG.;Primary end point(s): HbA1c | — |
Countries
Czech Republic, Lithuania
Outcome results
None listed