A Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX in Subjects With Type 2 Diabetes Mellitus (T2DM)

NCT02367066 | Completed Phase 1 Results

• 1 other identifier: D6420C00001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A study to assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated Doses for 3 days in Subjects with Type 2 Diabetes Mellitus

Conditions

Type 2 Diabetes Mellitus

Keywords

patients; glycaemic control on metformin

Outcome Measures

Primary Outcomes (3)

• Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Glucose

  MMTT=Mixed Meal Tolerance Test AUC=Area Under Curve

  Day -1 to Day 3 and Day 6 to Day 9

• Change From Baseline to Endpoint MMTT C_max for Plasma Glucose

  Day -1 to Day 3 and Day 6 to Day 9

• Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma C-Peptide

  GGI=Glucose and GLP1 infusion AUC=Area Under Curve

  Day -1 to Day 3 and Day 6 to Day 9

Secondary Outcomes (24)

• Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Insulin

  Day -1 to Day 3 and Day 6 to Day 9

• Change From Baseline MMTT AUC(0-4h) for Plasma Glucagon

  Day -1 to Day 3 and Day 6 to Day 9

• Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma C-Peptide

  Day -1 to Day 3 and Day 6 to Day 9

• Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Insulin

  Day -1 to Day 3 and Day 6 to Day 9

• Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Insulin

  Day -1 to Day 3 and Day 6 to Day 9

Study Arms (2)

AR-C165395XX + placebo

EXPERIMENTAL

1st period AR-C165395XX 2nd period placebo

Drug: AR-C165395XX

Placebo + AR-C165395XX

PLACEBO COMPARATOR

1st period Placebo for AR-C165395XX 2nd period AR-C165395XX

Other: Placebo

Interventions

AR-C165395XX DRUG

Oral dose of AR-C165395XX (tablets)

AR-C165395XX + placebo

Placebo OTHER

Oral dose of placebo for AR-C165395XX (tablets)

Placebo + AR-C165395XX

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent
• Male or female of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/tubal ligation) aged ≥18.
• Patients with HbA1c ≥7.5 but ≤11% at enrolment visit (Visit 1)
• ody mass index \>19 to \<38 kg/m2
• he fasting plasma glucose should be in the range of 3-14 mmol/L (54-252 mg/dL, nclusive) on the morning of Visit 1.
• Clinical diagnosis of type 2 diabetes mellitus
• Metformin as only anti-diabetic treatment, at least for the last 3 months

You may not qualify if:

• History or sign of any clinically significant disease or disorder which, in the opinion f the investigator, may either put the subject at risk because of participation in the sudy, or influence the results or the subject's ability to participate in the study
• Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) laboratory results \>3x upper level of normal range (ULN) Clinical diagnosis of Type 1 diabetes mellitus and/or history of diabetic ketoacidosis or positive Glutamic Acid Decarboxylase Autoantibodies test (GAD antibodies test).
• Patients treated with single Insulin therapy within the last 3 months

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Chula Vista, California, United States

Location

Related Publications (1)

• Skrtic S, Tyrberg B, Broberg M, Ericsson H, Schnecke V, Kjaer M, Hompesch M, Andersson EM, Ryberg E, Aivazidis A, Wennberg Huldt C, Lofgren L, Morrow L, Parkinson J, Ryden-Bergsten T, Watkins E, Sorhede Winzell M. Exploring the insulin secretory properties of the PGD2-GPR44/DP2 axis in vitro and in a randomized phase-1 trial of type 2 diabetes patients. PLoS One. 2018 Dec 17;13(12):e0208998. doi: 10.1371/journal.pone.0208998. eCollection 2018.

  PMID: 30557325 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Stanko Skrtic, MD, PhD
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Liliana Uribe-Bruce, MD, MCI

  Profil Institute for Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

• Stanko Skrtic, MD, PhD

  AstraZeneca R&D Mölndal

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: February 20, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 23, 2016
• Results First Posted: June 23, 2016

Record last verified: 2016-05

Locations

US (1)