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

NCT ID: NCT01281605

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 181 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2016-05-31

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active titration algorithm

titrate insulin dose by contacting with investigator by telephone weekly.

Group Type: ACTIVE_COMPARATOR

Active titration algorithm

Intervention Type: BEHAVIORAL

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).

Usual titration algorithm

contact with investigator only at routine study visit.

Group Type: EXPERIMENTAL

Usual titration algorithm

Intervention Type: BEHAVIORAL

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Insulin detemir active titration algorithm; Insulin detemir usual titration algorithm

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mackay Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sung-Chen Liu

Division of Endocrinology and Metabolism, Department of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sung-Chen Liu, MD

Role: STUDY_CHAIR

Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital

Hui-Fang Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Hsinchu branch

Ke-Yan Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Taitung branch

Locations

Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Hsinchu branch

Hsinchu, , Taiwan

Mackay Memorial Hospital

Taipei, , Taiwan

Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Taitung branch

Taitung, , Taiwan

Countries

Taiwan

Other Identifiers

10M MHIS112

Identifier Type: -

Identifier Source: org_study_id