A clinical trial to study the effects of combination of Rosuvastatin plus Teneligliptin Tablets in diabetic patients with high lipid levels.

Phase 3

Completed

• Conditions: Type 2 diabetes mellitus with circulatory complications,

• Registration Number: CTRI/2019/12/022548
• Lead Sponsor: Synokem Pharmaceuticals Ltd

Brief Summary

“A Phase III, Randomized, Double Blind, ParallelGroup, Non-Comparative Clinical Trial to Evaluate the Efficacy, Safety andTolerability of FDC of Rosuvastatin + Teneligliptin Tablets in patientssuffering from Dyslipidemia associated with Type 2 Diabetes Mellitus.â€

 **Primaryobjective:**To evaluate the efficacy of FDC of Rosuvastatin + Teneligliptin Tabletsin patients suffering from Dyslipidemia associated with Type 2 DiabetesMellitus.

 **Secondaryobjective:**To evaluate the safety and tolerability of FDC of Rosuvastatin + Teneligliptin Tabletsin patients suffering from Dyslipidemia associated with Type 2 DiabetesMellitus.

 Patients who arewilling and able to participate in the study will sign and date the InformedConsent Form on the day of screening / baseline visit (Visit 1). During thisscreening period, patients who are willing to give consent will be evaluatedfor all the eligibility criteria. Eligible patients aged between 18 to 65 years(both inclusive) and fulfilling all inclusion criteria and none of theexclusion criteria will be considered for the study.

 Patients will beassigned to either of the three arms i.e. Arm A or Arm B or Arm C consisting ofFDC of Rosuvastatin 5 mg + Teneligliptin 20 mg Tablets or FDC of Rosuvastatin10 mg + Teneligliptin 20 mg Tablets or FDC of Rosuvastatin 20 mg +Teneligliptin 20 mg Tablets. Patients will be given the study medication oncedaily for 12 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-30
• Last Update Posted: 2021-02-04
• Study Completion: 2021-02-22

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Male or female patients aged between 18 to 65 years (both inclusive).
• Patient diagnosed with Dyslipidemia and Type 2 diabetes defined as: LDL-C ≥ 100 mg/dl and ≤ 250 mg/dl & HbA1c Levels ≥ 7% and ≤ 8.5%.
• Patients who had receiving a stable dose of Metformin (≥ 1000 mg /day) for at least 3 months prior to screening.
• Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
• Patients willing to comply with the protocol requirements.

Exclusion Criteria

• Any known contraindications to Rosuvastatin or Teneligliptin or related class of drugs.
• Has clinical laboratory evaluations (including biochemistry and hematology) are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator.
• Patients with known case of type 1 diabetes mellitus.
• Patients with glycosylated hemoglobin (HbA1c) >8.5%.
• Patients with Body mass index (BMI) higher than 40 kg/m2.
• Patients with clinically significant impaired hepatic function [SGOT & SGPT more than 2.5X the UNL and/or Total bilirubin more than 1.5X the UNL].
• Patients with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2.
• Patients with the history of severe heart disease (angioplasty, stent placement, bypass surgery, myocardial infarction, unstable angina pectoris, New York Heart Association class III, IV congestive heart failure, or ventricular arrhythmia within 6 months before screening).
• Patients with known cases of diabetic nephropathy, diabetic ketoacidosis, diabetic coma, hyperglycemia hyperosmolar state, retinopathy, neuropathy.
• Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
• Females who are not ready to use acceptable contraceptive methods during the course of study.
• Patients with known case of clinically significant cerebrovascular disease, cardiovascular disease, gastric dysfunction, thyroid dysfunction, chronic uncontrolled systemic diseases like asthma, hypertension or other medical illness that may affect patient safety or difficult to evaluate the efficacy of the product.
• Patients who have participated in any clinical trial in the past 3 months.
• Patients who are known cases of HIV, Hepatitis B or Hepatitis C.
• Patients who have a recent history or who are currently known to abuse alcohol or drugs.
• Patients with medical history of Oncological Conditions since last 5 years.
• Currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
• Suspected inability or unwillingness to comply with the study procedures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Mean change in Low-Density Lipoprotein (LDL-C) from baseline to end of the study.	For LDL-C - At Week 4, Week 8 and Week 12 | For HbA1c - At Week 12
2. Mean change in glycosylated hemoglobin (HbA1c) from baseline to end of the study.	For LDL-C - At Week 4, Week 8 and Week 12 | For HbA1c - At Week 12

Secondary Outcome Measures

Name	Time	Method
Mean change in fasting plasma glucose (FPG) & 2-hr post prandial glucose (PPG) from baseline to end of the study.	At Week 4, Week 8 and Week 12

Trial Locations

Locations (14)

Apex Hospitals Private Limited; 🇮🇳 Jaipur, RAJASTHAN, India

Chirayu Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Down Town Hospital Ltd; 🇮🇳 Kamrup, ASSAM, India

Gandhi Medical College / Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Government Medical College & Government General Hospital (Old RIMSGGH); 🇮🇳 Srikakulam, ANDHRA PRADESH, India

GSVM Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

Jawahar Lal Nehru (J.L.N) Medical College; 🇮🇳 Jaipur, RAJASTHAN, India

Maharaja Agrasen Superspeciality Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Medical College and Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

NRS Medical College & Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

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Apex Hospitals Private Limited

🇮🇳Jaipur, RAJASTHAN, India

Dr Brij Mohan Goyal

Principal investigator

9413190570

drbrijmohan.goyal@gmail.com