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

This study is currently recruiting participants.
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
 Behavioral: Active titration algorithm
Behavioral: Usual titration algorithm
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Two Titration Programs of Adding Insulin Detemir to Oral Antidiabetic Drugs in Poorly Controlled Type 2 Diabetes Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mackay Memorial Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active titration algorithm
titrate insulin dose by contacting with investigator by telephone weekly.
 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
Experimental: Usual titration algorithm
contact with investigator only at routine study visit.
 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

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.
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01281605

Contacts
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

Locations
Taiwan
Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Hsinchu branch Recruiting
Hsinchu, Taiwan, 30067
Contact: Hui-Fang Chang, MD     886-968-964371        
Contact: Ya-Chun Hsiao, MD     886-3-611-9595 ext 6230        
Principal Investigator: Hui-Fang Chang, MD            
Sub-Investigator: Ya-Chun Hsiao, MD            
Mackay Memorial Hospital Recruiting
Taipei, Taiwan, 10449
Contact: Sung-Chen Liu, MD     886-968957754     pine3.tw@yahoo.com.tw    
Contact: Chao-Hung Wang, MD     886-2-2543-3535 ext 2174     cuojye@ms64.hinet.net    
Principal Investigator: Sung-Chen Liu, MD            
Sub-Investigator: Chao-Hung Wang, MD            
Sub-Investigator: Ming-Nan Chien, MD            
Sub-Investigator: Chun-Chuan Lee, MD            
Sub-Investigator: Ching-Hsiang Leung, MD            
Sub-Investigator: Wei Che Chen, MD            
Sub-Investigator: Jiun-Lu Li, MD            
Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Taitung branch Recruiting
Taitung, Taiwan, 95054
Contact: Ke-Yan Wu, MD     886-975747159     katyien@yahoo.com    
Principal Investigator: Ke-Yan Wu, MD            
Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Sung-Chen Liu, Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT01281605     History of Changes
Other Study ID Numbers: 10M MHIS112
Study First Received: January 20, 2011
Last Updated: October 11, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Mackay Memorial Hospital:
Type 2 diabetes
Basal insulin
Insulin detemir
Insulin titration algorithm

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Hypoglycemic Agents
Insulin, Long-Acting
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013