NCT01281605

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2011

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

August 20, 2018

Status Verified

March 1, 2016

Enrollment Period

4.8 years

First QC Date

January 20, 2011

Last Update Submit

August 16, 2018

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetesBasal insulinInsulin detemirInsulin titration algorithm

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

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

    12 weeks

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

    24 weeks

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

    24 weeks

  • To compare the change in body weight at each visit

    24 weeks

  • To evaluate the incidence of adverse events.

    24 weeks

Study Arms (2)

Active titration algorithm

ACTIVE COMPARATOR

titrate insulin dose by contacting with investigator by telephone weekly.

Behavioral: Active titration algorithm

Usual titration algorithm

EXPERIMENTAL

contact with investigator only at routine study visit.

Behavioral: Usual titration algorithm

Interventions

Active titration algorithmBEHAVIORAL

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).

Also known as: Insulin detemir active titration algorithm
Active titration algorithm
Usual titration algorithmBEHAVIORAL

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.

Also known as: Insulin detemir usual titration algorithm
Usual titration algorithm

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must meet all of the following criteria:
  • Men and women with type 2 diabetes.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Hsinchu, 30067, Taiwan

Location

Mackay Memorial Hospital

Taipei, 10449, Taiwan

Location

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

Taitung, 95054, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Sung-Chen Liu, MD

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

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division of Endocrinology and Metabolism, Department of Internal Medicine

Study Record Dates

First Submitted

January 20, 2011

First Posted

January 24, 2011

Study Start

January 1, 2011

Primary Completion

October 1, 2015

Study Completion

May 1, 2016

Last Updated

August 20, 2018

Record last verified: 2016-03

Locations

TW(3)