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Comparison of Insulin Detemir, Insulin Aspart and Biphasic Insulin Aspart 30 With OAD Treatment in Type 2 Diabetes

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes; Diabetes Mellitus, Type 2

Intervention: biphasic insulin aspart (Drug); insulin detemir (Drug); insulin aspart (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Jens Larsen, MD, Study Director, Affiliation: Novo Nordisk A/S

Summary

This trial is conducted in Europe. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir, insulin aspart and biphasic insulin aspart 30, when added to current OAD (oral anti-diabetic drug) treatment in subjects with type 2 diabetes and to verify the safety of use (number and severity of episodes of hypoglycaemia, body weight and side effects).

Clinical Details

Official title: A 36-month, Multi-centre, Open-label, Randomised, Parallel-group Trial Comparing the Safety, Efficacy and Durability of Adding a Basal Insulin Versus a Twice Daily Insulin Mixture Versus a Meal-time Rapid-Acting Insulin in Subjects With Type 2 Diabetes Inadequately Controlled on Therapy With Oral Agents, and Assessing the Requirement for More Complex Insulin Regimens to Achieve and Maintain Glycaemic Control, Their Efficacy and Durability

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

HbA1c (Glycosylated Haemoglobin) at Month 12

HbA1c (Glycosylated Haemoglobin) at Month 36

Secondary outcome:

Percentage of Participants (Total Participants and the Subset of Participants Who Did Not Have an Hypoglycaemic Episode) Achieving a Month 12 Value in HbA1c Below or Equal to 6.5%

Percentage of Participants Achieving a Month 36 Value in HbA1c Below or Equal to 6.5%

Number of Hypoglycaemic Events Per Participant Per Year at Month 12 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%

Number of Hypoglycaemic Events Per Participant Per Year at Month 36 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%

Percentage of Participants Who Required A Second Insulin Therapy by Month 12

Percentage of Participants Who Required A Second Insulin Therapy by Month 36

Change From Baseline in Body Weight at Month 12

Change From Baseline in Body Weight at Month 36

Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months

Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months

Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 12 Months

Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 36 Months

Number of Participants Having an 'Other' Adverse Event

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Type 2 diabetes

- Insulin naive

- On OAD treatment for at least 4 months with metformin, a sulphonylurea or a

combination

- Body Mass Index (BMI) below or equal to 40. 0 kg/m2

- HbA1c (glycosylated haemoglobin): 7. 0%-10% (both inclusive)

Exclusion Criteria:

- Proliferative retinopathy

- Recurrent major hypoglycaemia

- Cardial problems

- Uncontrolled hypertension

- Impaired hepatic or renal function

Locations and Contacts

Dublin, Ireland

Oxford, United Kingdom

Additional Information

Clinical Trials at Novo Nordisk

Starting date: November 2004
Last updated: May 23, 2012

Page last updated: August 23, 2015

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