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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Active titration algorithm; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Hsinchu, Taiwan, 30067
    • Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Hsinchu branch
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital
  • Taitung, Taiwan, 95054
    • Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Taitung branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Insulin detemir usual titration algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
To compare the change in body weight at each visit	compare the change in body weight at each visit	24 weeks
To evaluate the incidence of adverse events.	evaluate the incidence of adverse events including hypoglycemia and any other adverse event.	24 weeks

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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. 2022 Nov 2. doi: 10.1111/dom.14912. Online ahead of print.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: January 20, 2011
• First Submitted That Met QC Criteria: January 20, 2011
• First Posted (Estimate): January 24, 2011

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Basal insulin; Insulin detemir; Insulin titration algorithm
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Detemir
• Other Study ID Numbers: 10M MHIS112