Phase 1 N=20 Randomized Triple-blind Basic Science

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

Type 2 Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT02367066 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2016

Primary outcome: Primary: Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Glucose — 0.92; 0.98 h*nmol/L — p=0.02

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: AR-C165395XX (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: May 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Glucose	0.92; 0.98	0.02 sig
PRIMARY Change From Baseline to Endpoint MMTT C_max for Plasma Glucose	0.93; 0.97	0.06
PRIMARY Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma C-Peptide	1.05; 1.06	0.41
SECONDARY Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Insulin	0.99; 1.08	0.06
SECONDARY Change From Baseline MMTT AUC(0-4h) for Plasma Glucagon	1.02; 0.96	0.18
SECONDARY Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma C-Peptide	1.01; 1.09	0.04 sig
SECONDARY Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Insulin	1.01; 1.07	—
SECONDARY Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Insulin	1.03; 1.04	0.37
SECONDARY Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Glucagon	1.01; 0.97	—
SECONDARY Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Glucagon	1.01; 0.99	0.06
SECONDARY Change From Baseline to Endpoint Fasting Beta-cell Responsiveness	0.01; -0.00	0.45
SECONDARY Fasting Insulin at Endpoint	11.70; 11.40	—
SECONDARY Maximum Plasma AZD1981 Concentration at Steady-State, C_ss,Max	2507; 3662	—
SECONDARY Time of Maximum Plasma AZD1081 Concentration, t_ss,Max	2.00; 1.00	—
SECONDARY Plasma AZD1981 AUC(0-1h)	701.30; 2061	—
SECONDARY Plasma AZD1981 AUC(0-2h)	2071; 5016	—
SECONDARY Minimum Plasma AZD1981 Concentration at Steady-State, C_ss,Min	202.40; 376.20	—
SECONDARY Plasma AZD1981 AUC(1-2h)	1344; 2936	—
SECONDARY Plasma Paracetamol Maximum Concentration, C_max	8074; 7899	—
SECONDARY Time of Maximum Plasma Paracetamol Concentration, t_max	3.50; 3.50	—
SECONDARY Plasma Paracetamol AUC(0-t)	19730; 18850	—
SECONDARY Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma C-Peptide	1.02; 1.03	—
SECONDARY Change From Baseline to Endpoint GGI AUC(0-24h) for Plasma Glucose	0.96; 0.97	—
SECONDARY Plasma AZD1981 AUC(0-4h)	5793; NA	—
SECONDARY Plasma AZD1981 AUC(0-12h)	12460; NA	—
SECONDARY Plasma AZD1981 AUC(0-24h)	24930; NA	—
SECONDARY Apparent Oral Plasma AZD1981 at Steady-State, CL_ss/F	21.94; NA	—

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

Eligibility 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02367066). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.