Safety and Efficacy of Insulin NPH Compared to a New Insulin Formulation in Subjects With Type 2 Diabetes

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in South America. This trial aims for a comparison of the safety and efficacy of insulin NPH and a new insulin formulation on blood glucose control.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

Criteria

Inclusion Criteria:

• Type 2 diabetes for at least 12 months

• Current NPH treatment for at least 3 months - alone or as the only insulin in combination with OADs

• Body Mass Index (BMI) less than or equal to 40 kg/m2

• HbA1c less than or equal to 9.5%

• FPG less than or equal to 12 mmol/L

Exclusion Criteria:

• Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors

• Treatment with more than 1 IU/kg NPH insulin daily

• Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator

• Known or suspected allergy to trial products or related products

• Receipt of any investigational drug within one month prior to this trial

• Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers