None listed
Conditions
Interventions
Group 1 Type of group
Amaryl 4 mg + HOE 901 before bed, daily
Group name:Group 2 Type of group
Amaryl 4mg + NPH Insulin before bed, 1 / day
Sponsors
AVENTIS PHARMA S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Patients with Type 2 Diabetes Mellitus (no history of ketoacidosis) • History of treatment with AAO (any sulphonylurea, including Amaryl® or a combination of sulfonylurea with other AAOs such as metformin or acarbose) for at least Vi year (six months). The previous dose of sulfonylurea must be at least one dose equivalent to or greater than 4 mg of Amaryl®. • HbAlc values> 7.5% - 100mg / dl (5.5 mmol / 1) • No previous treatment with any insulin in the three months prior to the study • Men and women <75 years of age • Body mass index <35 kg / m2 • Ability and willingness to undergo a rigorous antidiabetic treatment and self-control of blood glucose and especially blood glucose profiles at home using a glucose meter, according to daily GSA measurements and full 8-blood glucose profile performed during a 24-hour period in the selection phase. • All patients must provide the Written Informed Consent before beginning the study in the visit I
Exclusion criteria
Exclusion criteria: • Pregnancy (according to blood pregnancy test in visit I) • Women who are breastfeeding • Fertile women who do not use a contraceptive method such as systemic hormones (contraceptive pills, implant), intrauterine device (IUD) or a barrier method (diaphragm with intravaginal spermicide, cervical plug, male or female condom) • Previous treatment with insulin in three months • Probability of requiring treatment during the study period with drugs not allowed by the study protocol (eg, p-blockers, systemic corticosteroids, see Section 6.2: Previous and concomitant treatments) • Treatment with any investigational drug in the three months before admission to the study • Treatment with HOE 901 in a previous study with HOE 901. • History of drug abuse or alcoholism • Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in 3 months at entry prices in the study or that may require surgical treatment in the three months after entering the study • After pancreatectomy. • Cardiovascular, gastrointestinal, hepatic, neurological, endocrine, hematological or other major systemic disease, clinically relevant, that hinders the development of the protocol or the interpretation of the results of the study • Insufficiency of liver function, determined but not limited to GPT (ALT) or GOT (AST) 2 times above the upper normal limit determined in visit I • Insufficiency of renal function, determined but not limited to serum creatinine> 177 umol / 1 (> 2.0 mg / dl) determined at visit I • Workers at night, in the event that they can not comply with the treatment as stipulated in the study protocol • Mental condition that prevents the patient from understanding the nature, scope and possible consequences of the study • Evidence of lack of cooperation, including non-compliance with any treatment (antidiabetic) • Impossibility to attend follow-up visits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Change from the baseline visit to the end point of the study for each patient. The endpoint of the study is defined as the patients last evaluation during treatment. Measure:Glycosylated hemoglobin HbA1c Timepoints:Last evaluation during treatment ; Outcome name:Serum glucose Measure:Frequency of patients with any hypoglycemic episode during the study Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:• The HbAlc response will be evaluated in 3 categories: 8% Responders will be patients with HbAlc 126 mg / dl GSA responders will be patients with GSA 7.5% (3) GSA> 100 mg / dl and HbAlc 100 mg / dl and HbAlc> 7.5% Measure:Response rates Timepoints:At the end of the study ; Outcome name:Change from the baseline visit to each visit. Measure:Glycosylated hemoglobin HbA1c Timepoints:On each visit ; Outcome name:Change in absolute mean GSA values, calculated from 5 determinations (2 consecutive blood glucose profiles of 8 points in 24 hours + 3 measurements documented in the diary) Measure:Fasting blood glucose (GSA) Timepoints:Before the baseline visit and the final point (endpoint) of the study. ; Outcome name:Change of the variance coefficients of the 5 determinations (2 consecutive blood glucose profiles of 8 points in 24 hours + 3 measurements documented in the diary) Measure:Fasting blood glucose variability (GSA) Timepoints:Before the baseline visit and the final point of the study. ; Outcome name:Change of absolute mean values of night blood glucose, calculated from 2 consecutive blood glucose profiles of 8 points in 24 hours Measure:Nocturnal blood glucose Timepoints:Before the baseline visit and the final point of the study. ; Outcome name:Change in the variance coefficients of the 2 consecutive night blood glucose values, calculated from 2 consecutive blood glucose profiles of 8 points in 24 hours Measure:Variability of night blood glucose Timepoints:Before the baseline visit and the final point of the study. ; Outcome name:Change in absolute values of mean daily blood glucose, calculated from 2 consecutive blood glucose profiles of 8 points in 24 hours Measure:Average daily blood glucose Timepoints:Before the baseline visit and the final point of the study. ; Outcome name:Change in the coefficients of variance of the 2 consecu | — |
Outcome results
None listed