Clinical trial NCT02027753: Efficacy and Safety of Insulin Glargine in Patients With Type 2 Diabetes With Inadequate Control on DPP-4 Inhibitor Therapy
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2014-01-06
Enrollment: 109
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

1. To assess the efficacy by adding insulin glargine
2. To assess insulin dose
3. Safety

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

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.

Primary outcomes:
measure: Response rate (percentage of patients who meet the target HbA1c ≤7%) at week 24 (6 months) after adding insulin therapy
timeFrame: week 24 (6 months)
Secondary outcomes:
measure: Percentage of patients with HbA1c ≤7%
timeFrame: week 12 (3 months)
measure: Change from baseline in HbA1c
timeFrame: week 12 (3 months), week 24 (6 months)
measure: Percentage of patients with HbA1c ≤6.5%
timeFrame: week 12 (3 months), week 24 (6 months)
measure: Change from baseline in Fasting Plasma glucose (FPG), 2hr-Postprandial Plasma Glucose
timeFrame: week 12 (3 months), week 24 (6 months)
measure: Total daily insulin dose
timeFrame: week 24 (6 months)
measure: Fasting blood glucose (FBG) values
timeFrame: During 3 consecutive days before baseline, week 12, Week 24
measure: 7-point Self Monitoring of Blood Glucose
timeFrame: During 2 days within 7 days before baseline, week 12, week 24
measure: Weight change from baseline
timeFrame: week 24 (6 months)
measure: Number of Patients with Hypoglycemic Events
timeFrame: up to 6 months
measure: Number of Patients with Adverse Events
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: