Nutritional, Metabolic, Endocrine: Diabetes Nutritional, Metabolic, Endocrine Diabetes
Conditions
Interventions
Insulin glargine titrated to a target pre-breakfast blood glucose level of <6.0 mmol/l (all patients) plus either nateglinidine (60mg increasing to 180mg) (intervention arm) or placebo (control arm) b
Sponsors
Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over 2. Type 2 diabetes (meeting the WHO definition of diabetes) 3. Using a human premix or NPH insulin for at least 3 months 4. HbA1c of 6.1-10.0 % 5. BMI inferior or equal to 42.0 kg/m2 6. Both men & women were eligible for recruitment, but women of childbearing potential were required to be using adequate contraception
Exclusion criteria
Exclusion criteria: 1. Significant hepatic dysfunction 2. Significant renal dysfunction 3. Active cardiovascular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Eight-point self-monitored blood glucose profiles (pre- and 1 h post-meals, bed-time, and 0300-0500 h) 2. Hypoglycaemia was classified as symptoms-only (with glucose levels above 3.0 mmol/l [54 mg/dl] or no test data), minor (confirmed =3.0 mmol/l), or severe (requiring third party assistance). 3. HbA1c measured by DCCT-aligned HPLC (this was the primary outcome) 4. Body weight | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed