None listed
Conditions
Interventions
Placebo tablets, taken 3 times daily.
Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily.
Group 1 Type of group
MK-0941 tablets 5 mg or 10 mg, taken 3 times daily, with increasing doses to maximally effective dose.
Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily.
Group name:Group 1 Type of group
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
21 Years to 70 Years
Inclusion criteria
Inclusion criteria: • The patient has type 2 diabetes (T2DM). • The patient is> 21 and ^ 0 years old on the day of signing the informed consent. • The patient has a body mass index (BMI)> 20 kg / m ^ 2 and 15 units / day for at least 6 weeks and has an A1C level> 7.5% and 7.5% and 85% compliance during the transition period with placebo in simple blind (determined by the tablet count performed on site).
Exclusion criteria
Exclusion criteria: • The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis, or the patient is evaluated by the investigator as possibly with type 1 diabetes confirmed with a C-peptide level 14 consecutive days or repeated cycles of pharmacological doses of systemic corticosteroids (oral, injectable / parenteral) or ocular during the study. • The patient has undergone surgery within 30 days prior to Visit 1 / Selection Visit or has planned major surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:HbA1c level blood test Measure:Change From Baseline in Hemoglobin A1c (HbA1c) Level Timepoints:Baseline (Day 1) and End of Treatment (Week 20) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Hypoglycemic episodes - with or without symptoms - are defined as a fingerstick glucose measurement of ≤70 mg/dL (3.9 mmol/L). Excludes data after initiation of glycemic rescue therapy. Measure:Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic) Timepoints:From first dose of study drug (Week 0) to last dose of study drug (Week 20) ; Outcome name:Fasting plasma glucose measurement by laboratory tests during the study. Measure:Change from baseline in fasting plasma glucose (FPG) in Week 20. Timepoints:Week 20 ; Outcome name:Measurement of total cholesterol, low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C] and triglycerides [TG] by laboratory tests during the study. Measure:Percentage change from baseline at Week 20 for endpoints measured or derived from the lipid panel (ie, total cholesterol, low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C ] and triglycerides [TG]). Timepoints:Week 20 | — |
Countries
Colombia, Denmark, Finland, France, India, New Zealand, Norway, Peru, Sweden, Turkey, United States
Contacts
Public Contactstela lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed