A Single Blind, (Subject and Investigator Blinded, Sponsor Unblinded), Two-Period, Placebo-Controlled, Randomized, Sequential, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DS 7309 In Subjects With Type 2 Diabetes Mellitus

DS-7309 is being developed for the treatment of type 2 diabetes mellitus (T2DM). This will be a randomized, placebo-controlled, blinded, sequential, multiple ascending dose study to assess the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of multiple doses of DS-7309 in subjects with T2DM.

Start Date01 Sep 2013

Sponsor / Collaborator

Daiichi Sankyo, Inc.

NCT01862939 / CompletedPhase 1

A Double Blind, Placebo-Controlled, Randomized, Two-Part, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DS-7309 in Healthy Volunteers and Subjects With Type 2 Diabetes Mellitus

This is a randomized, placebo-controlled, 2-part, sequential, single ascending dose study.
Part 1 is planned as 6 sequential escalation treatment groups. Part 2 is a randomized, placebo-controlled, two-period sequential pharmacodynamic (PD) arm.

Start Date01 Apr 2011

Sponsor / Collaborator

Daiichi Sankyo, Inc.

100 Clinical Results associated with DS-7309

100 Translational Medicine associated with DS-7309

100 Patents (Medical) associated with DS-7309

Literatures (Medical) associated with DS-7309

01 Mar 2022·Regulatory Toxicology and PharmacologyQ4 · MEDICINE

Effects of glucokinase activator, DS-7309, on embryo-fetal developmental toxicity in rats and rabbits

Q4 · MEDICINE

Article

Author: Yahagi, Satoko ; Kuwata, Chiharu ; Watanabe, Toshiyuki ; Matsuoka, Toshiki ; Shimomura, Kazuhiro ; Tsuchiya, Yoshimi ; Ohshima, Yoshiko

The toxicological effects of DS-7309, a glucokinase activator, on pregnancy and embryo-fetal development in rats and rabbits and maternal blood glucose levels were examined. DS-7309 was administered at 3, 10, or 100 mg/kg to rats from Days 7-17 of pregnancy or at 10, 30, or 100 mg/kg to rabbits from Days 6-18 of pregnancy. In rats, maternal hypoglycemia (approximately 50 mg/dL) was seen at 3 and 10 mg/kg, but it recovered 7 h after dosing, leading to no toxic changes. In contrast, continuous severe maternal hypoglycemia (approximately 40 mg/dL, ≥7 h), fetal eye anomalies, and decreased fetal body weight were noted at 100 mg/kg. In rabbits, no fetal anomalies were seen at 10 and 30 mg/kg where maternal blood glucose level dropped to approximately 60-90 mg/dL, but recovered by 7 h after dosing at the latest. In contrast, at 100 mg/kg, severe hypoglycemia (around 60 mg/dL) was maintained and did not recover until 24 h after dosing; it resulted in decreased fetal viability and increased fetal skeleton anomalies. These findings indicate that DS-7309 could lead to embryo-fetal toxicity in rats and rabbits, with such toxicity considered to be related to continuous severe maternal hypoglycemia.

100 Deals associated with DS-7309

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 1	US	Daiichi Sankyo, Inc.	01 Apr 2011

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