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

Diabetes Mellitus, Type 2 Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027753
• Other study ID #: LANTUL06638
• Secondary ID: U1111-1149-1632
• Status: Completed
• Phase: Phase 4
• First received: January 3, 2014
• Last updated: August 26, 2015
• Start date: December 2013
• Est. completion date: April 2015

Study information

• Verified date: August 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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:

1. To assess the efficacy by adding insulin glargine

2. To assess insulin dose

3. Safety

Description:

28 weeks (Screening: About 2 weeks/Treatment: 24 weeks (6 months)/Follow-up: 2 weeks)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• INSULIN GLARGINE
Pharmaceutical form: solution Route of administration: subcutaneous
• Metformin
Pharmaceutical form: tablet Route of administration: oral
• DPP-4 inhibitor
Pharmaceutical form: tablet Route of administration: oral
• Sulphonylurea
Pharmaceutical form: tablet Route of administration: oral

Locations

Country	Name	City	State
Korea, Republic of	Sanofi-Aventis Administrative Office	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate (percentage of patients who meet the target HbA1c =7%) at week 24 (6 months) after adding insulin therapy		week 24 (6 months)	No
Secondary	Percentage of patients with HbA1c =7%		week 12 (3 months)	No
Secondary	Change from baseline in HbA1c		week 12 (3 months), week 24 (6 months)	No
Secondary	Percentage of patients with HbA1c =6.5%		week 12 (3 months), week 24 (6 months)	No
Secondary	Change from baseline in Fasting Plasma glucose (FPG), 2hr-Postprandial Plasma Glucose		week 12 (3 months), week 24 (6 months)	No
Secondary	Total daily insulin dose		week 24 (6 months)	No
Secondary	Fasting blood glucose (FBG) values		During 3 consecutive days before baseline, week 12, Week 24	No
Secondary	7-point Self Monitoring of Blood Glucose		During 2 days within 7 days before baseline, week 12, week 24	No
Secondary	Weight change from baseline		week 24 (6 months)	No
Secondary	Number of Patients with Hypoglycemic Events		up to 6 months	Yes
Secondary	Number of Patients with Adverse Events		up to 6 months	Yes