Clinical trial NCT01281605: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Basal insulin
Insulin detemir
Insulin titration algorithm
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2011-01-24
Enrollment: 181
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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 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.

Primary outcomes:
measure: To compare the change in HbA1c between two study groups at Week 24.
timeFrame: 24 weeks
Secondary outcomes:
measure: To compare the change in HbA1C between two study groups at Week 12.
timeFrame: 12 weeks
measure: To compare the proportion of patients achieving HbA1C <7% at Week 24
timeFrame: 24 weeks
measure: To compare the changes in fasting plasma glucose (FPG) at Week 12 and 24.
timeFrame: 24 weeks
measure: To compare the change in body weight at each visit
timeFrame: 24 weeks
measure: To evaluate the incidence of adverse events.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Hsinchu branch
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taitung
country: Taiwan
facility: Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Taitung branch
Study officials:
affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital
name: Sung-Chen Liu, MD
role: STUDY_CHAIR
affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Hsinchu branch
name: Hui-Fang Chang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Taitung branch
name: Ke-Yan Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.