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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

1st period AR-C165395XX 2nd period placebo

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

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

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

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

NCT ID

Therapeutic Area

Oral dose of placebo for AR-C165395XX (tablets)

Research Site

Gender, Male/Female

Age Continuous

Race (NIH/OMB)

Ethnicity (NIH/OMB)

Weight

Study Specific Characteristic

Height

Body Mass Index

T2DM disease duration

Current Metformin Daily Dose

Percentage of glycosylated hemoglobin, DCCT

HbA1c

MMTT=Mixed Meal Tolerance Test
AUC=Area Under Curve

One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.


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

Change from Baseline to Endpoint MMTT C_max for Plasma Glucose

GGI=Glucose and GLP1 infusion
AUC=Area Under Curve

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

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

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

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

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

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

Change from Baseline to Endpoint GGI AUC(0-1h) for Plasma Glucagon

Change from Baseline to Endpoint GGI AUC(1-2h) for Plasma Glucagon

Change from Baseline to Endpoint Fasting Beta-cell responsiveness

One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.

Fasting Insulin at Endpoint

One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981. 

Maximum Plasma AZD1981 Concentration at Steady-State, C_ss,max

Time of Maximum Plasma AZD1081 Concentration, t_ss,max

Plasma AZD1981 AUC(0-1h)

Plasma AZD1981 AUC(0-2h)

Minimum Plasma AZD1981 Concentration at Steady-State, C_ss,min

Plasma AZD1981 AUC(1-2h)

Plasma Paracetamol Maximum Concentration, C_max

Time of Maximum Plasma Paracetamol Concentration, t_max

Plasma Paracetamol AUC(0-t)

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

Change from Baseline to Endpoint GGI AUC(0-24h) for Plasma Glucose

Plasma AZD1981 AUC(0-4h)

Plasma AZD1981 AUC(0-12h)

Plasma AZD1981 AUC(0-24h)

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

Overall Study

30 patients were enrolled in the study. 10 of these were screen failures, leaving 20 patients who started the started the study.

Dr. Stanko Skrtic, MD, PhD

Safety and tolerability after repeated oral doses of AR-C165395XX in T2DM

Arms	Assigned Interventions
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)

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

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Exclusion Criteria

Documents available

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator