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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Active titration algorithm
Usual titration algorithm
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Basal insulin, Insulin detemir, Insulin titration algorithm

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Active titration algorithm

Usual titration algorithm

Arm Description

titrate insulin dose by contacting with investigator by telephone weekly.

contact with investigator only at routine study visit.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
To compare the proportion of patients achieving HbA1C <7% at Week 24
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.
compare the changes in fasting plasma glucose (FPG) after 12 and 24 treatment.
To compare the change in body weight at each visit
compare the change in body weight at each visit
To evaluate the incidence of adverse events.
evaluate the incidence of adverse events including hypoglycemia and any other adverse event.

Full Information

First Posted
January 20, 2011
Last Updated
August 16, 2018
Sponsor
Mackay Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01281605
Brief Title
Comparison of Two Titration Programs of Adding Insulin Detemir to OADs in Poorly Controlled Type 2 Diabetes
Official Title
Comparison of Two Titration Programs of Adding Insulin Detemir to Oral Antidiabetic Drugs in Poorly Controlled Type 2 Diabetes Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabetes, Basal insulin, Insulin detemir, Insulin titration algorithm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active titration algorithm
Arm Type
Active Comparator
Arm Description
titrate insulin dose by contacting with investigator by telephone weekly.
Arm Title
Usual titration algorithm
Arm Type
Experimental
Arm Description
contact with investigator only at routine study visit.
Intervention Type
Behavioral
Intervention Name(s)
Active titration algorithm
Other Intervention Name(s)
Insulin detemir active titration algorithm
Intervention Description
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
Intervention Name(s)
Usual titration algorithm
Other Intervention Name(s)
Insulin detemir usual titration algorithm
Intervention Description
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.
Primary Outcome Measure Information:
Title
To compare the change in HbA1c between two study groups at Week 24.
Description
compare the change in HbA1c between two study groups after 24 weeks treatment.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
To compare the change in HbA1C between two study groups at Week 12.
Description
compare the change in HbA1C between two study groups after 12 of treatment.
Time Frame
12 weeks
Title
To compare the proportion of patients achieving HbA1C <7% at Week 24
Description
compare the proportion of patients achieving HbA1C <7% after 24 weeks treatment
Time Frame
24 weeks
Title
To compare the changes in fasting plasma glucose (FPG) at Week 12 and 24.
Description
compare the changes in fasting plasma glucose (FPG) after 12 and 24 treatment.
Time Frame
24 weeks
Title
To compare the change in body weight at each visit
Description
compare the change in body weight at each visit
Time Frame
24 weeks
Title
To evaluate the incidence of adverse events.
Description
evaluate the incidence of adverse events including hypoglycemia and any other adverse event.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung-Chen Liu, MD
Organizational Affiliation
Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hui-Fang Chang, MD
Organizational Affiliation
Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Hsinchu branch
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ke-Yan Wu, MD
Organizational Affiliation
Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Taitung branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Hsinchu branch
City
Hsinchu
ZIP/Postal Code
30067
Country
Taiwan
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Taitung branch
City
Taitung
ZIP/Postal Code
95054
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
36321411
Citation
Liu SC, Chuang SM, Wang CH, Chien MN, Lee CC, Chen WC, Leung CH, Lin JL. Comparison of two titration programmes for adding insulin detemir to oral antidiabetic drugs in patients with poorly controlled type 2 diabetes mellitus. Diabetes Obes Metab. 2023 Mar;25(3):700-706. doi: 10.1111/dom.14912. Epub 2022 Nov 25.
Results Reference
derived

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

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