Effect of Two Different Fasting Blood Glucose Targets on Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily

Phase 4

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin detemir

• Registration Number: NCT00634842
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in the United States of America. The aim of this trial is to explore how different fasting blood glucose targets affect glucose control in patients with type 2 diabetes, when patients are empowered to do dose adjustments themselves.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-06
• Study First Submitted QC: 2008-03-06
• Study First Posted: 2008-03-13
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2009-10-23
• Results First Submitted QC: 2009-11-17
• Results First Posted: 2009-12-22
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

Inclusion Criteria

• Type 2 diabetes
• 1-3 oral treatments
• Insulin naive
• BMI (Body Mass Index) less than or equal to 45

Exclusion Criteria

• Pregnancy
• Retinopathy
• Cardiac disease
• Uncontrolled hypertension
• Recurrent hypoglycaemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FPG 70-90 mg/dL	insulin detemir	Aggressive FPG (fasting plasma glucose) titration target range group
FPG 80-110 mg/dL	insulin detemir	Conventional FPG (fasting plasma glucose) titration target range group

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7%	week 20	Percentage (%) of subjects reaching glycosylated haemoglobin A1c (HbA1c) less than 7% measured after 20 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline	week -2, week 20	Change in glycosylated haemoglobin A1c (HbA1c) percentage from baseline measured from week -2 to week 20
Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5%	week 20	Percentage (%) of participants reaching glycosylated haemoglobin A1c (HbA1c) less than or equal to 6.5% measured after 20 weeks of treatment
Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)	weeks 0-20	Incidence of hypoglycaemic episodes (all, major, minor and symptoms only) occurring during the treatment period from week 0 to week 20. Classification was as follows: * If subject was unable to treat himself: Major incidence.; * If subject could treat himself and plasma glucose was less than 3.1 mmol/l: Minor incidence.; * If subject could treat himself and plasma glucose was equal to or greater than 3.1 mmol/l, or there was no plasma glucose measurement: Symptoms only.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇵🇷 Trujillo Alto, Puerto Rico