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

Novo Nordisk

Status and phase

Completed

Phase 2

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: EX1000

Drug: insulin NPH

Study type

Interventional

Funder types

Industry

Identifiers

NCT00660374

EX1000-1865

Details and patient eligibility

About

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.

Enrollment

402 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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