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

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ClinicalTrials.gov Identifier: NCT02367066
Recruitment Status : Completed
First Posted : February 20, 2015
Results First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: AR-C165395XX Other: Placebo Phase 1

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official 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
Study Start Date : March 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015


Arm Intervention/treatment
Experimental: AR-C165395XX + placebo
1st period AR-C165395XX 2nd period placebo
Drug: AR-C165395XX
Oral dose of AR-C165395XX (tablets)

Placebo Comparator: Placebo + AR-C165395XX
1st period Placebo for AR-C165395XX 2nd period AR-C165395XX
Other: Placebo
Oral dose of placebo for AR-C165395XX (tablets)




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02367066


Locations
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United States, California
Research Site
Chula Vista, California, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Liliana Uribe-Bruce, MD, MCI Profil Institute for Clinical Research, Inc.
Study Director: Stanko Skrtic, MD, PhD AstraZeneca R&D Mölndal
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02367066    
Other Study ID Numbers: D6420C00001
First Posted: February 20, 2015    Key Record Dates
Results First Posted: June 23, 2016
Last Update Posted: June 23, 2016
Last Verified: May 2016
Keywords provided by AstraZeneca:
patients
glycaemic control on metformin
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases