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AZD5658

Phase 1

Type 2 Diabetes | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Feb 2, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

AZD5658 · 1 trial · 1 indication

Phase 1 1
NCT01176097To Assess Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and the Effect of Fasting After Single Oral Doses of AZD5658 in Type 2 DiabetesType 2 Diabetes
COMPLETED24 Analytics
PHASE1COMPLETED
To Assess Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and the Effect of Fasting After Single Oral Doses of AZD5658 in Type 2 Diabetes
Type 2 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

To investigate the safety and tolerability of AZD5658 following oral administration of single ascending doses and to estimate the maximum tolerated dose (MTD).
AEs-, blood pressure and pulse during study days. Safety labs - day -1 to day 4; ECG - days 1, 2 and 3

Secondary Endpoints

To investigate the pharmacokinetics of AZD5658 after single ascending oral doses in type 2 diabetes mellitus patients.
Venous blood samples for the determination of concentrations of AZD5658 in plasma will be taken predose and at various times up to 72 hours postdose
Pharmacodynamics (plasma glucose and serum insulin)
Plasma glucose and serum insulin determined on Day -1 through Day 4
Effect of fasting on the pharmacokinetics and explore the pharmacodynamics of AZD5658.
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
6 - 8 cohortsEXPERIMENTAL6 patients in each cohort will receive AZD5658

Interventions

NameTypeDescription
AZD5658DRUGoral suspension, escalating single doses
PlaceboDRUGoral suspension,single doses
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Eligibility Criteria

Age Range20 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients must be of non-childbearing potential. * Body mass index between greater than or equal to 19 and less than or equal to 40 kg/m2 * Patients with confirmed Type 2 Diabetes diagnosis for at least 1 year and treated with Metformin Exclusion Criteria: * Clinically signif...

Countries:United States
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Frequently asked questions about AZD5658

What is AZD5658 used for?

AZD5658 is an investigational small molecule being developed for the treatment of Type 2 Diabetes. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied to assess its safety, tolerability, and effects in patients with this condition.

Who makes AZD5658?

AZD5658 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company is conducting clinical research on this investigational drug for the treatment of Type 2 Diabetes.

What phase is AZD5658 in?

AZD5658 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and tolerability. The drug is being studied for the treatment of Type 2 Diabetes.

What clinical trials is AZD5658 in?

AZD5658 has been studied in one completed Phase 1 clinical trial with the identifier NCT01176097. This trial assessed the safety, tolerability, pharmacokinetics, pharmacodynamics, and the effect of fasting after single oral doses of AZD5658 in patients with Type 2 Diabetes. The trial enrolled 24 participants and was conducted in the United States.

Is AZD5658 the same as any other drug?

AZD5658 is the primary name for this investigational drug. No alternative names have been established for this compound in the available clinical trial information. It is being developed by AstraZeneca PLC for the treatment of Type 2 Diabetes.