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NCT Number: NCT01281605

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

About this study

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:

  • Men and women with type 2 diabetes.
  • 20 years of age.
  • Patients who have received stable doses of any OADs for at least 10 weeks prior to the screening visit.
  • Patients with inadequate glycemic control (HbA1C >=7% and < 11%).
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients must meet all of the following criteria:

  • Men and women with type 2 diabetes.
  • 20 years of age.
  • Patients who have received stable doses of any OADs for at least 10 weeks prior to the screening visit.
  • Patients with inadequate glycemic control (HbA1C >=7% and < 11%).
  • Patients who are willing and able to cooperate with study and give signed informed consent.

Exclusion criteria

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

Treatment and study plan

Active titration algorithm

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).

Other names: Insulin detemir active titration algorithm

Usual titration algorithm

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.

Other names: Insulin detemir usual titration algorithm

Primary outcomes

  1. To compare the change in HbA1c between two study groups at Week 24.

    Time frame: 24 weeks

    compare the change in HbA1c between two study groups after 24 weeks treatment.

Secondary outcomes

  1. To compare the change in HbA1C between two study groups at Week 12.

    Time frame: 12 weeks

    compare the change in HbA1C between two study groups after 12 of treatment.

  2. To compare the proportion of patients achieving HbA1C <7% at Week 24

    Time frame: 24 weeks

    compare the proportion of patients achieving HbA1C <7% after 24 weeks treatment

  3. To compare the changes in fasting plasma glucose (FPG) at Week 12 and 24.

    Time frame: 24 weeks

    compare the changes in fasting plasma glucose (FPG) after 12 and 24 treatment.

  4. To compare the change in body weight at each visit

    Time frame: 24 weeks

    compare the change in body weight at each visit

  5. To evaluate the incidence of adverse events.

    Time frame: 24 weeks

    evaluate the incidence of adverse events including hypoglycemia and any other adverse event.

Sponsors and collaborators

Lead sponsor

Mackay Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Jan 24, 2011
Registry last updated
Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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