Initial Combination With Pioglitazone Study (0431-064)

A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Initial Therapy With Coadministration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-119-06

Enrollment

Registered

2007-05-07

Start date

2007-06-20

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

GROUP 1 Type of group

Transition period: Patients will be treated with Sitagliptin Placebo, in tablets, PO, QD, for 2 weeks. Double-blind treatment period: This group will be treated as Sitagliptin Placebo, in 100 mg tablets, at a dose of 100 mg, PO, QD + Pioglitazone, in 30 mg tablets, at a dose of 30 mg, PO, QD

GROUP 2 Type of group

Transition period: Patients will be treated with Sitagliptin Placebo, in tablets, PO, QD, for 2 weeks. Period of treatment in double blind: This group will be treated as Sitagliptin, in 100 mg tablets, at a dose of 100 mg, PO, QD + Pioglitazone, in 30 mg tablets, at a dose of 30 mg, PO, QD

this scheme will continue for 24 weeks.

Eligibility

Inclusion criteria

Inclusion criteria: HbA1c ≥ 8.0% and ≤ 12.0% in Visit 1 / Screening Visit.

Exclusion criteria

Exclusion criteria: Glucose obtained by fasting digital puncture performed at the site 320 mg / dL (17.8 mmol / L) at Visit 3 / Day 1.

Design outcomes

Primary

Measure	Time frame
Outcome name:Levels of glycosylated hemoglobin (HbA1c) in peripheral blood. Measure:Change with respect to baseline in HbA1c. Timepoints:Week 24.	—

Secondary

Measure	Time frame
Outcome name:Criterion 1: Peripheral blood glucose levels after 2 hours at a standard meal exposure (Postprandial Glucose - PPG). Criteria 2 and 3: Determination of glucose levels after a fasting period (fasting plasma glucose - FPG). Measure:Secondary efficacy: 1) Change from baseline in the PPG after 2 hours. 2) Change from baseline in FPG in Week 24. 3) Change from baseline in FPG in Week 1. Timepoints:Week 24. ; Outcome name:riterion 1: Evaluation of the proportion of change in insulin at 30 minutes with respect to the change in glucose at 30 minutes after a test of tolerance to food. Criterion 2-5: Determination of serum levels of the evaluated elements after 0, 30 and 120 minutes of a food tolerance test. Criteria 6 and 7: Mathematical determination of insulin resistance and beta cell reserve based on criteria 2-5 values. Criterion 8: Serum levels of 1,5-anhydroglucitol. Criteria 9-10: Determination of the area under the curve (AUC) of glucose and insulin levels after a food tolerance test. Criterion 11: Serum levels of LDL-C, HDL-C, and triglycerides. Measure:Change with respect to the baseline in: 1) Insulininogenic index. 2) proinsulin. 3) Proinsulin proportion to insulin. 4) Concentrations of preprandial insulin and 2 hours postprandial. 5) Peptide C, 6) HOMA-B. 7) HOMA-IR. 8) 1,5-anhydroglucitol. 9) Total AUC and AUC of the oscillation. 10) Ratio of AUC of glucose with respect to AUC of insulin. 11) Percentage change of lipid parameters. Timepoints:Week 24. ; Outcome name:Criterion 1: Clinical evaluation of any unfavorable and unplanned change in the structure, function or biochemistry of the body temporarily associated with the use of the product under investigation. Criterion 2: Panels of serum chemistry and hematology, urine test. Criterion 3: A calibrated digital scale will be used. Criterion 4: Measurement of blood pressure, heart rate, temperature, respiratory rate. Criterion 5: P	—

Measure

Time frame

Outcome name:Criterion 1: Peripheral blood glucose levels after 2 hours at a standard meal exposure (Postprandial Glucose - PPG). Criteria 2 and 3: Determination of glucose levels after a fasting period (fasting plasma glucose - FPG). Measure:Secondary efficacy: 1) Change from baseline in the PPG after 2 hours. 2) Change from baseline in FPG in Week 24. 3) Change from baseline in FPG in Week 1. Timepoints:Week 24. ; Outcome name:riterion 1: Evaluation of the proportion of change in insulin at 30 minutes with respect to the change in glucose at 30 minutes after a test of tolerance to food. Criterion 2-5: Determination of serum levels of the evaluated elements after 0, 30 and 120 minutes of a food tolerance test. Criteria 6 and 7: Mathematical determination of insulin resistance and beta cell reserve based on criteria 2-5 values. Criterion 8: Serum levels of 1,5-anhydroglucitol. Criteria 9-10: Determination of the area under the curve (AUC) of glucose and insulin levels after a food tolerance test. Criterion 11: Serum levels of LDL-C, HDL-C, and triglycerides. Measure:Change with respect to the baseline in: 1) Insulininogenic index. 2) proinsulin. 3) Proinsulin proportion to insulin. 4) Concentrations of preprandial insulin and 2 hours postprandial. 5) Peptide C, 6) HOMA-B. 7) HOMA-IR. 8) 1,5-anhydroglucitol. 9) Total AUC and AUC of the oscillation. 10) Ratio of AUC of glucose with respect to AUC of insulin. 11) Percentage change of lipid parameters. Timepoints:Week 24. ; Outcome name:Criterion 1: Clinical evaluation of any unfavorable and unplanned change in the structure, function or biochemistry of the body temporarily associated with the use of the product under investigation. Criterion 2: Panels of serum chemistry and hematology, urine test. Criterion 3: A calibrated digital scale will be used. Criterion 4: Measurement of blood pressure, heart rate, temperature, respiratory rate. Criterion 5: P

—

Countries

Brazil, Chile, Costa Rica, Czech Republic, India, Korea South, Lithuania, Malasya, Peru, Philippines, Puerto Rico, Russian Federation, United States

Contacts

Public ContactStela Lopez

MERCK SHARP & DOHME PERU S.R.L

stela_lopez@merck.com4115935

Outcome results