Study to Evaluate Safety Tolerability Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes

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Recruiting
participants needed

36
sponsor

Akros Pharma Inc.

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Updated on 19 February 2024

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body mass index

plasma glucose

fasting

metformin

Summary

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JTT-662 administered once daily for 28 days in subjects with Type 2 diabetes mellitus (T2DM) who are receiving metformin monotherapy

Details

Condition	NIDDM, diabetes mellitus, type 2, diabetes mellitus, type 2
Age	18-65 years
Treatment	Placebo, JTT-662
Clinical Study Identifier	NCT04465877
Sponsor	Akros Pharma Inc.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Diagnosis of T2DM for at least 12 weeks prior to the Screening Visit
	Currently treated with a stable oral dose of metformin for at least 12 weeks prior to the Screening Visit
	Have a glycosylated hemoglobin (HbA1c) value of between 6.5% and 10.0% at the Screening Visit
	Have a fasting plasma glucose (FPG) value of no more than 280 mg/dL at the Screening Visit and on Day -3
	Body Mass Index (BMI) of 25 to 40 kg/m2 (inclusive)
	Must be willing to wear a continuous glucose monitor (CGM) device
Exclusion Criteria
	Known medical history or presence of Type 1 diabetes mellitus, Maturity Onset Diabetes of the Young or secondary forms of diabetes
	Known medical history or presence of diabetic complications
	Have taken anti-diabetic medications (other than metformin) or medications that act mainly in the gastrointestinal tract (e.g., orlistat, acarbose) within 12 weeks prior to the Screening Visit or from the Screening Visit to Day -3
	Have uncontrolled hypertension (systolic blood pressure of at least 160 mmHg or diastolic blood pressure of at least 95 mmHg) at the Screening Visit
	Have impaired renal function (estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2)

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Study to Evaluate Safety Tolerability Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes