None listed
Conditions
Interventions
Group 1 Type of group
Tabletas de sitagliptina, por via oral, a una dosis de 100 mg o 50 mg QD durante 30 semanas. El nivel de dosis que se administrara dependera de la tasa de filtracion glomerular estimada (TFGe) del participante, calculada en la visita 3 y puede ajustarse segun lo indicado medicamente durante el estudio. + Coincidencia de tabletas de placebo con glimepirida para permitir el cegamiento.
Group name:Group 2 Type of group
Glimepiride tablets, orally, starting at a dose of 1 mg QD, which may be gradually increased, as needed, to maximum dose of 6 mg QD for 30 weeks. The dose may also be decreased as medically indicated during the study. + Matching placebo tablets to sitagliptin to allow for blinding.
Sponsors
MERCK & CO.INC.,
Eligibility
Age
65 Years to 85 Years
Inclusion criteria
Inclusion criteria: • Patient is =65 and =85 years of age with T2DM and is community-dwelling. • Patient is not on AHA (for =12 weeks) and has an A1C of =7.0% and =9.0%. OR Patient is on oral AHA monotherapy or low-dose combination therapy (i.e., approximately =50% of maximum dose of each agent) and has a Visit 1 A1C of =6.5% and =8.5%. • Patient understands the study procedures, alternative treatments available, and a risk involved with the study, and voluntarily agrees to participate by giving written informed consent. • Patient has an A1C of =7.0% and =9.0%. • Patient has 85% compliance (as measured by tablet count) with single-blind placebo tablets during run-in.
Exclusion criteria
Exclusion criteria: • Patient has a history of type 1 diabetes mellitus (T1DM) or a history of ketoacidosis. OR Patient is assessed by the investigator as possibly having T1DM supported by a C-peptide <0.7 ng/mL (<0.23 nmol/L). • Patient has been on an investigational or approved dipeptidyl peptidase-4 (DPP-4) inhibitor agent. •Patient has been on glucagon-like peptide-1 (GLP-1) analogues or mimetics (e.g., liraglutide, exenatide, etc.) or insulin within the prior 8 weeks. • Patient has been on a PPAR agonist within the prior 16 weeks. • Patient has a hypersensitivity or contraindication to any sulfonylurea (e.g., glimepiride) medication. • Patient is on a weight loss program and is not in the maintenance phase, or has been started on a weight loss medication (e.g., orlistat or sibutramine) within the prior 8 weeks. • Patient is on or likely to require treatment with =14 consecutive days or repeated courses of pharmacologic doses of corticosteroids. • Patient has untreated hyperthyroidism or is currently under treatment for hyperthyroidism. • Patient has undergone a surgical procedure within the prior 4 weeks. • Patient is currently participating in or has participated in another study with an investigational compound or device within the prior 12 weeks and does not agree to refrain from participating in any other study while participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Participant whole blood samples were collected at baseline and Week 30 to determine the LS mean HbA1c change from baseline. HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation. Measure:Least Squares (LS) Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 30 Timepoints:Baseline and Week 30 ; Outcome name:Symptomatic hypoglycemia was defined as an episode with clinical symptoms attributed to hypoglycemia, without regard to glucose level. Participants were instructed to complete the Hypoglycemia Assessment Log (HAL) for any symptomatic episodes he or she believed represent hypoglycemia. If a fingerstick glucose was obtained before or shortly (i.e., within a few minutes) after treating, the value was recorded in the HAL. In addition, participants were instructed to record in the HAL any fingerstick glucose values ≤70 mg/dL (≤3.9 mmol/L) regardless of the presence of clinical symptoms. Measure:Number of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 30 Timepoints:Up to Week 30 ; Outcome name:An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the treatment administered. Measure:Number of Participants Experiencing An Adverse Event (AE) Timepoints:Up to Week 30 ; Outcome name:An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the treatment administered. Measure:Number of Participants Discontinuing Study Treatment Due to An AE Timepoints:Up to Week 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Plasma samples were collected from participants after an overnight fast at baseline and Week 30 to determine the mean change from baseline in participant FPG. Measure:LS Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30 Timepoints:Baseline and Week 30 ; Outcome name:Participant whole blood samples were collected at Week 30 to determine the number of participants achieving HbA1c <7.0% at Week 30. HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation. Measure:Percentage of Participants With HbA1c <7.0% at Week 30 Timepoints:Week 30 ; Outcome name:Participant whole blood samples were collected at Week 30 to determine the number of participants achieving HbA1c <6.5% at Week 30. Hemoglobin A1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation. Measure:Percentage of Participants With HbA1c <6.5% at Week 30 Timepoints:Week 30 ; Outcome name:Participants were only permitted to wear a drape gown and undergarments (no street clothes, no shoes or socks) for this evaluation. Body weight was measured after voiding (to the nearest 0.1 kg) and measurements were collected until 2 consecutive measurements did not differ by more than 0.2 kg from each other. Body weight measurements were evaluated using a standardized, calibrated digital scale and was reported in kilograms (kg) at baseline and Week 30. Measure:LS Mean Change From Baseline in Participant Body Weight at Week 30 Timepoints:Baseline and Week 30 | — |
Countries
Argentina, Australia, Bulgaria, Chile, Colombia, Guatemala, Israel, Malasya, New Zealand, Philippines, United Kindgdom, United States
Contacts
Public ContactAnibal Enrique Salas
COVANCE PERU SERVICES S.A.
Outcome results
None listed