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

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Active titration algorithm; Behavioral: Usual titration algorithm

• Registration Number: NCT01281605
• Lead Sponsor: Mackay Memorial Hospital

Brief 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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-01-20
• Study First Posted: 2011-01-24
• Primary Completion: 2015-10
• Status Verified: 2016-03
• Study Completion: 2016-05
• Last Update Submitted: 2018-08-16
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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.

Exclusion Criteria

1. Patients with type 1 diabetes.
2. Renal dialysis patients.
3. History of hypoglycemia unawareness.
4. Patients who had received any insulin for more than 2 weeks or who have received insulin treatment within 4 weeks prior to screening visit.
5. Patients who have received any investigational products (drug and device) within 4 weeks prior to screening visit.
6. Patients hypersensitive with insulin detemir or its excipients.
7. Patients who are currently pregnant/lactating,or who are preparing for pregnancy or lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active titration algorithm	Active titration algorithm	titrate insulin dose by contacting with investigator by telephone weekly.
Usual titration algorithm	Usual titration algorithm	contact with investigator only at routine study visit.

Primary Outcome Measures

Name	Time	Method
To compare the change in HbA1c between two study groups at Week 24.	24 weeks	compare the change in HbA1c between two study groups after 24 weeks treatment.

Secondary Outcome Measures

Name	Time	Method
To compare the proportion of patients achieving HbA1C <7% at Week 24	24 weeks	compare the proportion of patients achieving HbA1C \<7% after 24 weeks treatment
To evaluate the incidence of adverse events.	24 weeks	evaluate the incidence of adverse events including hypoglycemia and any other adverse event.
To compare the change in HbA1C between two study groups at Week 12.	12 weeks	compare the change in HbA1C between two study groups after 12 of treatment.
To compare the changes in fasting plasma glucose (FPG) at Week 12 and 24.	24 weeks	compare the changes in fasting plasma glucose (FPG) after 12 and 24 treatment.
To compare the change in body weight at each visit	24 weeks	compare the change in body weight at each visit

Trial Locations

Locations (3)

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan

Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Hsinchu branch; 🇨🇳 Hsinchu, Taiwan

Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Taitung branch; 🇨🇳 Taitung, Taiwan