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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Mackay Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Sung-Chen Liu, Mackay Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01281605
First received: January 20, 2011
Last updated: October 11, 2012
Last verified: October 2012

January 20, 2011
October 11, 2012
January 2011
June 2013   (final data collection date for primary outcome measure)
To compare the change in HbA1c between two study groups at Week 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
compare the change in HbA1c between two study groups after 24 weeks treatment.
To compare the change in A1C between two study groups at Week 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01281605 on ClinicalTrials.gov Archive Site
  • To compare the change in HbA1C between two study groups at Week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    compare the change in HbA1C between two study groups after 12 of treatment.
  • To compare the proportion of patients achieving HbA1C <7% at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    compare the proportion of patients achieving HbA1C <7% after 24 weeks treatment
  • To compare the changes in fasting plasma glucose (FPG) at Week 12 and 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    compare the changes in fasting plasma glucose (FPG) after 12 and 24 treatment.
  • To compare the change in body weight at each visit [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    compare the change in body weight at each visit
  • To evaluate the incidence of adverse events. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    evaluate the incidence of adverse events including hypoglycemia and any other adverse event.
To compare the proportion of patients achieving HbA1C <7% at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  1. To compare the change in HbA1C between two study groups at Week 12.
  2. To compare the proportion of patients achieving HbA1C <7% at Week 24.
  3. To compare the changes in fasting plasma glucose (FPG) at Week 12 and 24.
  4. To compare the change in body weight at each visit.
  5. To evaluate the incidence of adverse events.
Not Provided
Not Provided
 
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

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • 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).
    Other Name: Insulin detemir active titration algorithm
  • 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.
    Other Name: Insulin detemir usual titration algorithm
  • Active Comparator: Active titration algorithm
    titrate insulin dose by contacting with investigator by telephone weekly.
    Intervention: Behavioral: Active titration algorithm
  • Experimental: Usual titration algorithm
    contact with investigator only at routine study visit.
    Intervention: Behavioral: Usual titration algorithm
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
July 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact: Sung-Chen Liu, MD 886-968957754 pine3.tw@yahoo.com.tw
Contact: Chao-Hung Wang, MD 886-2-2543-3535 ext 2173 cuojye@ms64.hinet.net
Taiwan
 
NCT01281605
10M MHIS112
Yes
Sung-Chen Liu, Mackay Memorial Hospital
Mackay Memorial Hospital
Not Provided
Study Chair: Sung-Chen Liu, MD Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital
Principal Investigator: Hui-Fang Chang, MD Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Hsinchu branch
Principal Investigator: Ke-Yan Wu, MD Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Taitung branch
Mackay Memorial Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP