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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01281605
• Other study ID #: 10M MHIS112
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: May 2016

Study information

• Verified date: March 2016
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: May 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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).
• 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.

Locations

Country	Name	City	State
Taiwan	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

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the change in HbA1c between two study groups at Week 24.	compare the change in HbA1c between two study groups after 24 weeks treatment.	24 weeks
Secondary	To compare the change in HbA1C between two study groups at Week 12.	compare the change in HbA1C between two study groups after 12 of treatment.	12 weeks
Secondary	To compare the proportion of patients achieving HbA1C <7% at Week 24	compare the proportion of patients achieving HbA1C <7% after 24 weeks treatment	24 weeks
Secondary	To compare the changes in fasting plasma glucose (FPG) at Week 12 and 24.	compare the changes in fasting plasma glucose (FPG) after 12 and 24 treatment.	24 weeks
Secondary	To compare the change in body weight at each visit	compare the change in body weight at each visit	24 weeks
Secondary	To evaluate the incidence of adverse events.	evaluate the incidence of adverse events including hypoglycemia and any other adverse event.	24 weeks