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Efficacy and Safety of Insulin Glargine in Patients With Type 2 Diabetes With Inadequate Control on DPP-4 Inhibitor Therapy (TED)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
INSULIN GLARGINE
Metformin
DPP-4 inhibitor
Sulphonylurea
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

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

Inclusion criteria :

  • Patients with type 2 Diabetes mellitus ≥ 20 aged
  • Patients who are treated with DPP- 4 for at least 3 months before informed consent with metformin plus or minus sulphonylurea inadequately controlled with HbA1c ≥ 7.5%
  • Be able and voluntarily agree to participate in this study by signing a written informed consent

Exclusion criteria:

  • Diabetes patients other than Type 2 (eg. Type 1 Diabetes mellitus, pancreatic disease, secondary diabetes)
  • HbA1c > 11% at screening
  • History of continuous basal insulin treatment within 1 year before screening
  • History of diabetic acidosis (including keto-acidosis) within 1 year before screening
  • History of myocardial infarct, stroke or heart failure related admission within 3 months before screening
  • History of drug or alcoholic abuse within 6 months before screening
  • Weight change ≥ 5 kg within 3 months before screening
  • History of hypoglycemic unawareness
  • Systolic blood pressure >180 mmHg or diastolic blood pressure > 110 mmHg regardless of taking anti-hypertensive, or uncontrolled hypertension
  • Active malignant cancer, major systemic disease, clinically significant diabetic retinopathy, macular edema necessitating laser treatment, abnormal clinical finding from physical examination, lab analysis, electrocardiogram or vital sign, which can be regarded as to prevent safe completion of clinical study or to make efficacy assessment difficult by investigator or co-investigator at screening
  • Pregnant or lactating women
  • Women of child bearing potential (Pre-menopause or not surgically infertile within 3 months before screening) who match two conditions below:
  • Negative serum pregnancy test at screening
  • Using medically proven effective contraceptive method
  • Hypersensitivity to investigational drugs
  • Lab finding at screening:
  • Abnormal liver function: Alanine transaminase or Alkaline phosphatase > 3 times of upper limit of normal range
  • Renal insufficiency: Men with serum Cr ≥ 1.5 mg/dL (≥ 133µmol/L), women with serum Cr ≥ 1.4 mg/dL (≥ 124 µmol/L)
  • Use of anti-obese drug within 3 months before screening
  • Has been using drugs that can influence glucose metabolism (systemic corticosteroid, thyroid hormone) within 3 months before screening or has possibility of using these drug during the investigational period
  • Has participated in clinical studies of any investigational drugs within 3 months before screening
  • Considered not physically or psychologically appropriate to participate in clinical study by investigator
  • Not willing to comply with scheduled visit, self-inject insulin, or self-monitor blood glucose level

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Insulin glargine and Oral anti diabetic treatment(s)

Arm Description

Insulin glargine: Lantus Add basal insulin: starting with 0.2 U/kg/day or 10 U/day Adjust insulin glargine dose according to Fasting blood glucose Oral Anti Diabetic treatment(s): DPP-4 inhibitors and Metformin plus or minus Sulphonylurea - Only Sulphonylurea can either be omitted or reduced at the physician's discretion.

Outcomes

Primary Outcome Measures

Response rate (percentage of patients who meet the target HbA1c ≤7%) at week 24 (6 months) after adding insulin therapy

Secondary Outcome Measures

Percentage of patients with HbA1c ≤7%
Change from baseline in HbA1c
Percentage of patients with HbA1c ≤6.5%
Change from baseline in Fasting Plasma glucose (FPG), 2hr-Postprandial Plasma Glucose
Total daily insulin dose
Fasting blood glucose (FBG) values
7-point Self Monitoring of Blood Glucose
Weight change from baseline
Number of Patients with Hypoglycemic Events
Number of Patients with Adverse Events

Full Information

First Posted
January 3, 2014
Last Updated
August 26, 2015
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT02027753
Brief Title
Efficacy and Safety of Insulin Glargine in Patients With Type 2 Diabetes With Inadequate Control on DPP-4 Inhibitor Therapy
Acronym
TED
Official Title
Efficacy and Safety of TrEating Type 2 Diabetic Patients With Inadequate Response to Metformin and DPP-4 Inhibitors by Adding Basal Insulin Therapy (Insulin Glargine)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary Objective: To investigate the efficacy(HbA1c) at 6 months after adding basal insulin therapy (insulin glargine) to dipeptidyl peptidase-IV (DPP-IV) and metformin plus or minus sulphonylurea Secondary Objectives: To assess the efficacy by adding insulin glargine To assess insulin dose Safety
Detailed Description
28 weeks (Screening: About 2 weeks/Treatment: 24 weeks (6 months)/Follow-up: 2 weeks)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin glargine and Oral anti diabetic treatment(s)
Arm Type
Experimental
Arm Description
Insulin glargine: Lantus Add basal insulin: starting with 0.2 U/kg/day or 10 U/day Adjust insulin glargine dose according to Fasting blood glucose Oral Anti Diabetic treatment(s): DPP-4 inhibitors and Metformin plus or minus Sulphonylurea - Only Sulphonylurea can either be omitted or reduced at the physician's discretion.
Intervention Type
Drug
Intervention Name(s)
INSULIN GLARGINE
Intervention Description
Pharmaceutical form: solution Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Pharmaceutical form: tablet Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
DPP-4 inhibitor
Intervention Description
Pharmaceutical form: tablet Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Sulphonylurea
Intervention Description
Pharmaceutical form: tablet Route of administration: oral
Primary Outcome Measure Information:
Title
Response rate (percentage of patients who meet the target HbA1c ≤7%) at week 24 (6 months) after adding insulin therapy
Time Frame
week 24 (6 months)
Secondary Outcome Measure Information:
Title
Percentage of patients with HbA1c ≤7%
Time Frame
week 12 (3 months)
Title
Change from baseline in HbA1c
Time Frame
week 12 (3 months), week 24 (6 months)
Title
Percentage of patients with HbA1c ≤6.5%
Time Frame
week 12 (3 months), week 24 (6 months)
Title
Change from baseline in Fasting Plasma glucose (FPG), 2hr-Postprandial Plasma Glucose
Time Frame
week 12 (3 months), week 24 (6 months)
Title
Total daily insulin dose
Time Frame
week 24 (6 months)
Title
Fasting blood glucose (FBG) values
Time Frame
During 3 consecutive days before baseline, week 12, Week 24
Title
7-point Self Monitoring of Blood Glucose
Time Frame
During 2 days within 7 days before baseline, week 12, week 24
Title
Weight change from baseline
Time Frame
week 24 (6 months)
Title
Number of Patients with Hypoglycemic Events
Time Frame
up to 6 months
Title
Number of Patients with Adverse Events
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria : Patients with type 2 Diabetes mellitus ≥ 20 aged Patients who are treated with DPP- 4 for at least 3 months before informed consent with metformin plus or minus sulphonylurea inadequately controlled with HbA1c ≥ 7.5% Be able and voluntarily agree to participate in this study by signing a written informed consent Exclusion criteria: Diabetes patients other than Type 2 (eg. Type 1 Diabetes mellitus, pancreatic disease, secondary diabetes) HbA1c > 11% at screening History of continuous basal insulin treatment within 1 year before screening History of diabetic acidosis (including keto-acidosis) within 1 year before screening History of myocardial infarct, stroke or heart failure related admission within 3 months before screening History of drug or alcoholic abuse within 6 months before screening Weight change ≥ 5 kg within 3 months before screening History of hypoglycemic unawareness Systolic blood pressure >180 mmHg or diastolic blood pressure > 110 mmHg regardless of taking anti-hypertensive, or uncontrolled hypertension Active malignant cancer, major systemic disease, clinically significant diabetic retinopathy, macular edema necessitating laser treatment, abnormal clinical finding from physical examination, lab analysis, electrocardiogram or vital sign, which can be regarded as to prevent safe completion of clinical study or to make efficacy assessment difficult by investigator or co-investigator at screening Pregnant or lactating women Women of child bearing potential (Pre-menopause or not surgically infertile within 3 months before screening) who match two conditions below: Negative serum pregnancy test at screening Using medically proven effective contraceptive method Hypersensitivity to investigational drugs Lab finding at screening: Abnormal liver function: Alanine transaminase or Alkaline phosphatase > 3 times of upper limit of normal range Renal insufficiency: Men with serum Cr ≥ 1.5 mg/dL (≥ 133µmol/L), women with serum Cr ≥ 1.4 mg/dL (≥ 124 µmol/L) Use of anti-obese drug within 3 months before screening Has been using drugs that can influence glucose metabolism (systemic corticosteroid, thyroid hormone) within 3 months before screening or has possibility of using these drug during the investigational period Has participated in clinical studies of any investigational drugs within 3 months before screening Considered not physically or psychologically appropriate to participate in clinical study by investigator Not willing to comply with scheduled visit, self-inject insulin, or self-monitor blood glucose level The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Insulin Glargine in Patients With Type 2 Diabetes With Inadequate Control on DPP-4 Inhibitor Therapy

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