NCT01281605

Comparison of Two Titration Programs of Adding Insulin Detemir to OADs in Poorly Controlled Type 2 Diabetes

Comparison of Two Titration Programs of Adding Insulin Detemir to Oral Antidiabetic Drugs in Poorly Controlled Type 2 Diabetes Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Mackay Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study compared the effectiveness and safety of two treatment algorithms for insulin detemir initiation and titration: active titration algorithm (performed by investigator weekly) versus usual titration algorithm (performed by study subjects weekly) in patients with type 2 diabetes poorly controlled by OADs.

Detailed description

This is a 24-week, prospective, open-label, randomized, parallel-group study conducted in approximately 200 patients with type 2 diabetes in the Taiwan. The effectiveness of insulin detemir will be assessed at baseline and at 12 and 24 weeks after initiation of study prescription. The safety will be followed during the 24-week study period. Inclusion criteria: Patients must meet all of the following criteria: 1. Men and women with type 2 diabetes. 2. 20 years of age. 3. Patients who have received stable doses of any OADs for at least 10 weeks prior to the screening visit. 4. Patients with inadequate glycemic control (HbA1C \>=7% and \< 11%). 5. Patients who are willing and able to cooperate with study and give signed informed consent. After enrollment, eligible patients will be randomized in a 1:1 ratio to one of the following titration algorithms: * Active titration algorithm: contact with investigator by telephone weekly. * Usual titration algorithm: contact with investigator only at routine study visit.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Active titration algorithm	Patients in active titration algorithm group will contact with investigator by telephone weekly to self-adjust the insulin dose till they achieve the target of FPG(\<110mg/dl).
BEHAVIORAL	Usual titration algorithm	All patients will be instructed to self-measure fasting capillary blood glucose. The dose of insulin detemir will be adjusted based on the average of three consecutive FPG values. the daily insulin dose should be increased by 2 IU/day if the FPG\>=110mg/dL, and by 4 IU/day if the FPG\>=180 mg/dL without any intervening hypoglycemic episodes; or it should be decreased by 2 or 4 IU/day if the FPG \< 70 mg/dL.

Timeline

• Start date: 2011-01-01
• Primary completion: 2015-10-01
• Completion: 2016-05-01
• First posted: 2011-01-24
• Last updated: 2018-08-20

Locations

3 sites across 1 country: Taiwan