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Completed

NCT Number: NCT02367066

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Chula Vista, California, United States

About this study

A Single Centre, Double-blind, Randomised, Placebo-controlled, Cross-over Phase I Study to Assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated Doses for 3 days in Subjects with Type 2 Diabetes Mellitus

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

AR-C165395XX

Drug

Oral dose of AR-C165395XX (tablets)

Placebo

Other

Oral dose of placebo for AR-C165395XX (tablets)

Primary outcomes

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

    Time frame: Day -1 to Day 3 and Day 6 to Day 9

    MMTT=Mixed Meal Tolerance Test AUC=Area Under Curve

  2. Change From Baseline to Endpoint MMTT C_max for Plasma Glucose

    Time frame: Day -1 to Day 3 and Day 6 to Day 9

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

    Time frame: Day -1 to Day 3 and Day 6 to Day 9

    GGI=Glucose and GLP1 infusion AUC=Area Under Curve

Secondary outcomes

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

    Time frame: Day -1 to Day 3 and Day 6 to Day 9

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

    Time frame: Day -1 to Day 3 and Day 6 to Day 9

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

    Time frame: Day -1 to Day 3 and Day 6 to Day 9

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

    Time frame: Day -1 to Day 3 and Day 6 to Day 9

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

    Time frame: Day -1 to Day 3 and Day 6 to Day 9

  6. Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Glucagon

    Time frame: Day -1 to Day 3 and Day 6 to Day 9

  7. Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Glucagon

    Time frame: Day -1 to Day 3 and Day 6 to Day 9

  8. Change From Baseline to Endpoint Fasting Beta-cell Responsiveness

    Time frame: Day -1 to Day 3 and Day 6 to Day 9

  9. Fasting Insulin at Endpoint

    Time frame: Day 3 and Day 9

  10. Maximum Plasma AZD1981 Concentration at Steady-State, C_ss,Max

    Time frame: Days 2,3,8,9

  11. Time of Maximum Plasma AZD1081 Concentration, t_ss,Max

    Time frame: Days 2,3,8,9

  12. Plasma AZD1981 AUC(0-1h)

    Time frame: Days 2,3,8,9

  13. Plasma AZD1981 AUC(0-2h)

    Time frame: Days 2,3,8,9

  14. Minimum Plasma AZD1981 Concentration at Steady-State, C_ss,Min

    Time frame: Days 2,3,8,9

  15. Plasma AZD1981 AUC(1-2h)

    Time frame: Days 2,3,8,9

  16. Plasma Paracetamol Maximum Concentration, C_max

    Time frame: Days 3,9

  17. Time of Maximum Plasma Paracetamol Concentration, t_max

    Time frame: Days 3,9

  18. Plasma Paracetamol AUC(0-t)

    Time frame: Days 3,9

  19. Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma C-Peptide

    Time frame: Day -1 to Day 3 and Day 6 to Day 9

  20. Change From Baseline to Endpoint GGI AUC(0-24h) for Plasma Glucose

    Time frame: Day -1 to Day 3 and Day 6 to Day 9

  21. Plasma AZD1981 AUC(0-4h)

    Time frame: Days 2,3,8,9

  22. Plasma AZD1981 AUC(0-12h)

    Time frame: Days 2,3,8,9

  23. Plasma AZD1981 AUC(0-24h)

    Time frame: Days 2,3,8,9

  24. Apparent Oral Plasma AZD1981 at Steady-State, CL_ss/F

    Time frame: Days 2,3,8,9

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Single Centre, Double-blind, Randomised, Placebo-controlled, Cross-over Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX After Administration of Repeated Doses for 3 Days in Subjects With Type 2 Diabetes Mellitus

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 20, 2015
Registry last updated
Jun 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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