A comparative Phase III clinical study of Insulin Glargine in Adults with Type 2 Diabetes.
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2021/11/037994
- Lead Sponsor
- M J Biopharm Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Willing to provide the written informed consent
2. Male and female adult patients, at an age of 18 to 65 years, both inclusive
3. Type 2 diabetes mellitus based on the disease diagnostic criteria provided by World Health Organization (WHO) guidelines
4. Duration of diabetes mellitus greater than or equal to 12 months
5. Receiving 2 or more Oral Antidiabetic Medicinal products (OAMs) at stable doses for 12 weeks prior to screening, with or without Lantus�®. The use and dose of oral agents in combination with insulin had to be in accordance with the product label. If on Lantus, must be on once daily stable dose (�±15% variation in dose) for at least 3 months prior to screening.
6. Haemoglobin level of �9.0 g/dL
7. Glycosylated haemoglobin (HbA1c) between 7.5% and 10.5%.
8. Body mass index (BMI) between 18 and 38 kilograms/meter square (kg/m�²)
9. Stable weight, with no significant and appreciable loss or gain, in the 3 months prior to screening; this information will be obtained by patient interview during medical history
10. Female patients of childbearing potential, in addition to having a negative serum pregnancy test, must be willing to use a reliable means of contraception (other than hormonal contraceptives) e.g. barrier method (diaphragm, condom, etc.), surgical sterilization (at least 6 months prior to study drug administration) or abstinence for the duration of the study. Patients should use the reliable method of contraception from screening, during study and up to and for at least two weeks after treatment discontinuation
11. Ability and willingness to administer study medication daily as injections to abdomen, thigh, or upper arm
12. As determined by the investigator, the patient should be capable and willing to do the following:
a. Perform self-monitored blood glucose (SMBG)
b. Complete Subject diaries as instructed
c. Be receptive to diabetes education
d. Be able and willing to adhere to the protocol requirements
1. Type 1 diabetes mellitus
2. Used any other insulin except Lantus�® within the previous 30 days. Have been on Lantus�® more than once daily within the previous 30 days.
3. Exposed to a biosimilar insulin glargine within the previous 90 days
4. History of taking basal bolus therapy or, in the investigatorââ?¬•s opinion, required mealtime insulin to achieve target control
5. Type 2 Diabetes patients with metabolic complications such as diabetic ketoacidosis within 6 months of screening visit
6. Used glucagon-like peptide 1 (GLP-1) agonist within the previous 90 days
7. Used thiazolidinediones (TZDs) within the previous 90 days
8. Excessive insulin resistance at study entry (total insulin dose �1.5 U/kg)
9. More than one episode of severe hypoglycemia defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, within 6 months prior to study entry
10. Known hypersensitivity or allergy to insulin glargine or its excipients OR history of significant allergic drug reactions
11. Receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy at pharmacological doses (excluding topical, intra-articular, intra-ocular, or inhalational preparations and physiologic replacement doses for adrenal deficiency) or had received such therapy within 4 weeks prior to screening
12. Inadequately treated hypertension (systolic �150 mm Hg or diastolic �100 mm Hg)
13. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 60 mL/min/1.73 m2 at screening.
14. Evidence of hypokalemia (serum potassium < 3.5 mmol/L at screening)
15. Known case of chronic liver disease or hepatic impairment, defined as any serum liver enzymes (alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, alkaline phosphatase) � 2.5 times ULN at screening
16. Congestive heart failure (New York Heart Association [NYHA] class III & class IV), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism or any other established major cardiovascular disease prior to screening
17. History of or ongoing cardiac dysrhythmias requiring treatment, such as uncontrolled atrial fibrillation
18. Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardize patientââ?¬•s safety or compliance with the protocol
19. Active cancer or personal history of cancer within previous 5 years (with the exception of basal cell carcinoma or carcinoma in situ)
20. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness, or positive HIV seropositivity at screening
21. Known active or chronic hepatitis B or hepatitis C infection, or Hepatitis B and Hepatitis C seropositivity at screening, if not related to vaccination
22. Blood transfusion or severe blood loss within 3 months prior to screening, or known haemoglobinopathy, hemolytic anemia, or sickle cell anemia
23. Prohibited medications which cannot be discontinued at randomization or anticipated initiation or change in concomitant medications known to affect glucose metabolism
24. Breastfeeding, pregnant,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in HbA1c from baseline to Week 24 compared with Lantus�®Timepoint: From baseline to end of treatment period (Week 24)
- Secondary Outcome Measures
Name Time Method Change in FPG and PPPG from baseline to Week 12 and Week 24Timepoint: From baseline to Week 12 and Week 24;Mean change in HbA1c from baseline to Week 12 compared with Lantus�®Timepoint: From baseline to Week 12;Proportion of patients with HbA1c reduction of â�¥1% from baseline to Week 12 and Week 24Timepoint: From baseline to Week 12 and Week 24