This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatments insulin aspart and detemir (novorapid, levemir), human regular insulin and nph insulin (actrapid, protaphne)
Phase phase 4
Sponsor Munich Municipal Hospital
Collaborator Novo Nordisk A/S
Start date July 2004
End date March 2009
Trial size 120 participants
Trial identifier NCT00747409, AnaHum


Compared to human insulins analogue insulins offer the option of optimizing metabolism also in type 2 diabetes. Especially, fast acting insulin analogues lower postprandial glucose levels more effectively than human regular insulin. However, it is not known whether therapy with analogue insulins can also improve the subclinically impaired myocardial function in type 2 diabetes. This prospective, randomized, open long term study compared the effects of a basal-bolus insulin therapy with analogue insulins versus human insulins on metabolic control and systolic and diastolic myocardial function, testing the hypothesis that optimized postprandial glucose control improves cardiac function and cardiovascular risk.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
(Active Comparator)
use of human regular insulin and NPH insulin
human regular insulin and nph insulin (actrapid, protaphne) Insulin Actrapid, Insulin Protaphne
basal-bolus therapy with human regular and NPH insulin
(Active Comparator)
use of insulin aspart and insulin detemir
insulin aspart and detemir (novorapid, levemir) Insulin NovoRapid, Insulin Levemir
use of basal-bolus therapy with insulin aspart and detemir

Primary Outcomes

postprandial blood glucose at the end of the study and its change from baseline.
time frame: 24-48 months treatment period

Secondary Outcomes

diastolic myocardial function
time frame: 24-48 months treatment

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

Inclusion Criteria: - type 2 diabetes, insulin therapy Exclusion Criteria: - type 1 diabetes, BMI >40, pregnancy,

Additional Information

Official title Randomized, Long-Term Study About the Effects of Analogue Versus Human Insulin Based Regimens (Insulin Detemir and Aspart Versus NPH- and Regular Human Insulin) on Metabolic Control and Myocardial Function in People With Type 2 Diabetes.
Principal investigator Petra-Maria Schumm-Draeger, MD, PHD
Description This is a single centre, long term (24-48 months), therapy controlled and randomised study with blinded analysis of the ultrasound data in 120 patients with type 2 diabetes mellitus and with previous insulin therapy. After recruitment and informed consent, patients are randomized to two treatment arms according to a randomisation protocol which takes into account age and absence or presence of cardiovascular events in each patient's history. In one treatment arm, the intensive insulin therapy is based on human insulin (insulin NPH and regular human insulin) while in the other arm, the intensive insulin therapy is based on analogue insulin (insulin detemir and insulin aspart). Both treatment arms will be titrated to identical glycemic goals (fasting blood glucose <110 mg/dL and post prandial blood glucose <150 mg/dL). All patients will be updated in their skills of self medication by the departmental diabetic teaching programme und will receive life style instructions during each visit. Furthermore, they are encouraged to keep records of any episode of hypoglycemia throughout the study. Outpatient visits for metabolic control are every 3 months and ultrasound and blood tests every 6 months.
Trial information was received from ClinicalTrials.gov and was last updated in September 2008.
Information provided to ClinicalTrials.gov by Munich Municipal Hospital.