A study to assess effectiveness and safety of Insulin inhalation powder as compared to placebo inhalation powder in patients with type 2 Diabetes Mellitus.
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2020/09/027550
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 216
A) At screening, for entering in the run-in period:
1.Subject/LAR is willing to sign the informed consent form
2.Male or female, aged 18 to 65 years (both inclusive)
3.Subject has been diagnosed with T2DM at least 12 months prior to screening visit
4.Receiving tolerated dose of OADs and on stable doses before enrollment.
5.Subject has HbA1c between 7.5% and 10.5% (both inclusive) and FPG <250 mg/dL.
6.No treatment with inhaled or injectable insulin, except during an acute illness, gestational diabetes
7.Subject agrees to have regular inhalations of insulin and use self-monitoring glucose device (glucometer) for recording blood glucose values as required by protocol.
8.Subject, in the opinion of the investigator, understands and is willing, able, and likely to comply with all study procedures and restrictions.
B) Subject has to satisfy the following glycemic criteria at the end of run-in period, prior to randomization to treatment period:
9.Subject has HbA1c between 7.5% and 10.5% (both inclusive) and FPG <250 mg/dL.
1.Subject has BMI >35 kg/m2.
2.Subject has hypersensitivity to human insulin or any of its excipients.
3.Subject is diagnosed with asthma, chronic obstructive pulmonary disease, any other significant respiratory disease, or has FEV1/FVC <70% of predicted value.
4.Subject is a current smoker or has discontinued smoking within 6 months prior screening.
5.Subject has clinically significant abnormality on chest X-ray.
6.Use of glucagon-like peptide 1 receptor agonists, thiazolidinediones, or weight loss drugs in the past 3 months.
7.Subject has clinically significant major organ system disease.
8.Subject has had a myocardial infarction or stroke within 6 months prior to screening.
9.Subject is predisposed to severe hypoglycemia (=2 severe episodes within 6 months prior to screening) or has had any hospitalization or emergency department visit due to poor diabetes control within 6 months prior to screening.
10.Subject is currently using systemic glucocorticoids or other drugs that alter glucose metabolism
Note: Topical/ ophthalmic/ intraarticular/ nasal spray corticosteroids will be allowed.
11.Subject has a clinically significant abnormal ECG at screening.
12.Subject has clinically significant abnormal laboratory values for Liver function test, Renal function test and Thyroid stimulating hormone at screening.
13.Subject has history of recent blood transfusion or diagnosis of hemoglobinopathies
14.Subject has history of malignancy within 5 years of screening (other than basal cell carcinoma).
15.Subject is known to have any drug or alcohol dependence.
16.Subject is currently using or has used alternative or herbal medicines prior to screening.
17.Premenopausal women who:
a.are nursing or pregnant or
b.are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
c.Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable, or injectable contraceptives, sexual abstinence, double barrier method and vasectomized partner.
18.Subject has participated in any clinical trial in last 3 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare the change in HbA1c from between TI and placebo groupsTimepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Compare the change in fasting plasma glucose (FPG) from between TI and placebo groupsTimepoint: 12 Weeks and 24 Weeks;Compare the change in HbA1c from between TI and placebo groupsTimepoint: 24 Weeks;Compare the proportion of subjects achieving HbA1c =7% between TI and placebo groups;Timepoint: 12 Weeks and 24 Weeks;Compare the proportion of subjects requiring rescue treatment for hyperglycaemia between TI and placebo groups.Timepoint: over 24 weeks