Differences in glucose production, lipolysis and proteolysis during different BASal INsulins, in patients with type two diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus type 2 (DM type II); Nutritional, Metabolic, Endocrine; Diabetes mellitus

• Registration Number: ISRCTN71468135
• Lead Sponsor: Academic Medical Centre (AMC) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-30
• Study Completion: 2008-08-01
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

1. Caucasian male patients with Diabetes Mellitus Type Two (DM II)
2. Basal bolus insulin therapy with NPH, detemir or glargine for at least one year
3. Basal insulin dosage: 30 ± 10 U
4. Fasting plasma glucose: 7.5 - 10.0 mmol/l
5. HbA1c 7.5 - 9%
6. Age 40 to 65 years
7. Body Mass Index (BMI) 26 - 30 kg/m^2

Exclusion Criteria

1. Major flaws in injection technique, as indicated by subcutaneous infiltration
2. Creatinine greater than 100 µmol/L or diabetic nephropathy
3. Abnormal liver enzymes (greater than 2 x upper limit of normal) and fasting triglycerides greater than 3 mmol/L
4. Clinically manifest autonomic neuropathy
5. Macrovascular complications of DM II, except for peripheral arterial disease
6. Epilepsy
7. Drugs interfering with insulin sensitivity and lipolysis, other than metformin
8. Alcohol abuse (greater than 5/day)
9. Fever/infection
10. Dietary fat content greater than 75%

Study & Design

• Study Type: Interventional
• Study Design: Not specified