A multi-center study to compare the effectiveness and safety of two different insulin injectable suspensions in treatment of patients diagnosed with type 2 diabetes mellitus
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2017/02/007763
- Lead Sponsor
- MJ Biopharm Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Patients eligible for enrolment in the study must meet all of the following criteria:
1.Male or female patients 18 to 65 years of age (both inclusive)
2.Patients who have been diagnosed with T2DM for at least 1 year prior to baseline visit
3.Patients have been receiving a stable dose of premix human insulin biphasic 30/70 (30% human insulin soluble injection and 70% human insulin isophane suspension) for at least 3 months prior to baseline visit
4.Patients with glycated haemoglobin level <= 11 % at screening
5.Patients willing to provide signed written informed consent
6.Patients willing to comply all aspects of the protocol
7.Ability to self-inject insulin and perform SMBG measurements. Patients whose injection is being administered by caregiver/family member (only in the case wherein the patient has fear to self-inject or does not prefer to self-inject) will be enrolled
Patients meeting any of the following criteria must not be enrolled:
1.Patients with history or evidence of hypersensitivity to insulin or its excipients
2.Patient who has received/receiving insulin of animal origin
3.Patient with history or evidence of recurrent severe hypoglycaemia within 6 months at baseline visit
4.Patients with uncontrolled T2DM, diabetic ketoacidosis requiring hospitalization within 6 months at baseline visit
5.Patients with use of insulin pump within 6 months at baseline visit
6.Patients whose requirement for total daily dose of insulin is > 1 IU/kg
7.Patients with serum AIA level above 20 U/mL
8.Patientâ??s having the any of the following laboratory results at screening
a.BUN > 30 mg/dL
b.ALT/AST levels >= 2.5 X ULN of the normal laboratory range
c.Serum creatinine level >2.0 mg/dL
9.Patients who have positive serology for hepatitis B virus (HBV) or hepatitis C (HCV) or human immunodeficiency virus (HIV) infections
10.Patients receiving glucagon-like peptide 1 mimetics (GLP-1)
11.Patients receiving treatment with thiazolidinedione (TZD) within the last 3 months at baseline visit
12.Women of childbearing potential not willing to use acceptable method of contraception
13.Women who are pregnant or nursing mothers
14.Patients with body mass index (BMI) <18 kg/m² and >= 40 kg/m² at screening
15.Patients who have undergone pancreatectomy or pancreas islet transplant or renal transplant
16.Patients receiving or have received within the last year any immunomodulation medications that would possibly modify antibody generation either at the enrollment or during the course of the study
17.Patients who have received/receiving ( > 14 consecutive days) glucocorticoids within 4 weeks prior to baseline visit
18.Patients with history or evidence of diabetic complications (diabetic retinopathy, diabetic neuropathy, or diabetic nephropathy), other complications related to T2DM other than those mentioned, or cardiac disorders, etc. which in the opinion of the investigator signifies patientsâ?? ineligibility for the trial
19.Patients with alcohol or drug abuse or any other medical or surgical condition, including lifestyle (e.g. shift workers, irregularity with meal times, etc.) that in the opinion of investigator can interfere with the study protocol or affect patientâ??s safety in the study
20.Has participated in any other clinical trial 6 months before the study entry
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HbA1c from baselineTimepoint: 12 Weeks and 24 weeks
- Secondary Outcome Measures
Name Time Method Efficacy: <br/ ><br>1.Proportion of patients with change in HbA1c <br/ ><br>2.Change in insulin dose between the two treatment arms <br/ ><br>3.Change in FPG and PPG <br/ ><br>4.Change in body weight <br/ ><br>Immunogenicity: <br/ ><br>1.Correlation between the % change in HbA1c and % change in AIA with absolute change in total insulin dose as covariate <br/ ><br>2.Compare the change in level of serum AIA <br/ ><br>Safety: <br/ ><br>1.Adverse events including clinically significant laboratory change that occur during the studyTimepoint: Baseline, Week 12 and Week 24