Phase 3
N=202
Clinical Trial of Efficacy and Safety of Subetta in the Treatment of Impaired Glucose Tolerance
Impaired Glucose Tolerance
Bottom Line
View on ClinicalTrials.gov: NCT03725033 ↗Enrolled (actual)
202
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Change 2-hour Plasma Glucose (During Oral Glucose Tolerance Test). — 9.27; 9.11; 7.28; 8.32 mmol/L — p=0.0028
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Subetta (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Materia Medica Holding
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change 2-hour Plasma Glucose (During Oral Glucose Tolerance Test). |
9.27; 9.11; 7.28; 8.32; -1.99; -0.79 | 0.0028 sig |
| SECONDARY Percentage of Patients With 2-hour Plasma Glucose <7.8 mmol / L. |
64; 46 | 0.0805 |
| SECONDARY Change in Fasting Plasma Glucose. |
5.83; 5.88; 6.01; 6.02; 0.18; 0.14 | 0.99 |
| SECONDARY Change in HbA1c |
5.9; 6.0; 5.8; 5.9; -0.1; -0.1 | 0.79 |
Summary
Purpose of the study:
* to assess the efficacy of Subetta in the treatment of impaired glucose tolerance
* to assess the safety of Subetta in the treatment of impaired glucose tolerance.
Eligibility Criteria
Inclusion Criteria
- Outpatients aged 18 to 70 years.
- Impaired glucose tolerance (plasma glucose from 7.8 to 11.0 mmol / L 2 hours after a 75 g oral glucose consumption during an oral glucose tolerance test, while fasting plasma glucose 160 mm Hg and/or diastolic blood pressure > 110 mm Hg.
- Acute coronary syndrome, myocardial infarction, acute impairment of cerebral circulation during the previous 6 months prior to enrollment.
- Unstable or life-threatening arrhythmia during the previous 3 months prior to enrollment.
- Acute and chronic heart failure with functional class III or IV (according to the classification of the New York Heart Association, 1964).
- Respiratory failure.
- Chronic kidney disease (classes C3-5 A3).
- Hepatic insufficiency (class C according to Child-Pugh).
- Presence or suspicion of oncology disease.
- The presence of an allergy / hypersensitivity to any component of the medication administered during the treatment.
- Alcohol consumption > 2 alcohol units for males and > 1 alcohol unit for females per day.
- Mental illness or drug abuse in anamnesis.
- Bariatric surgery in anamnesis, any surgery for 3 months before enrollment.
- Pregnancy, breast-feeding; childbirth less than 3 months before enrollment.
- Participation in other clinical trials for 3 months before enrollment in this study.
- Patients who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).
- Patients who work for MATERIA MEDICA HOLDING (i.e. the company's employees, temporary contract workers, appointed officials responsible for carrying out the research or immediate relatives of the aforementioned).
Data sourced from ClinicalTrials.gov (NCT03725033). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.