A Study of 28431754 (Canagliflozin) on Gastrointestinal Glucose Absorption and Metabolism in Healthy Volunteers

NCT01173549 | Completed Phase 1

• 2 other identifiers: CR01722428431754DIA1022
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of canagliflozin on gastrointestinal glucose absorption in healthy volunteers.

Conditions

Healthy

Keywords

Canagliflozin; Pharmacodynamic; Glucose absorption; Glucose metabolism

Outcome Measures

Primary Outcomes (1)

• The amount of ingested glucose that is absorbed in systemic circulation

  During the first 1 and 2 hours after a standard mixed meal

Secondary Outcomes (5)

• The amount of ingested glucose that is absorbed in systemic circulation

  2-6 hr and 0-6 hr after a standard mixed meal

• Endogenous glucose production (EGP)

  At protocol-specified time points after a standard mixed meal

• Total and incremental plasma glucose and insulin area under the curve (AUC)

  0-1, 0-2, 2-6, and 0-6 hours after a standard mixed meal

• Gastric emptying: peak level, time to peak level, and AUCs

  0-6 hours after a standard mixed meal

• Rate of Peripheral glucose disposal (Rd)

  At protocol-specified time points after a standard mixed meal

Study Arms (2)

001

EXPERIMENTAL

no intervention Part 1: 240 mL water 10 minutes (min) prior to the start of the MMTT on Day 1 of Periods 1 and 2. Periods 1 and 2 will be separated by 7 to 21 days.

Other: no intervention

002

EXPERIMENTAL

Canagliflozin/Placebo Placebo/Canagliflozin Part 2: 240 mL water 20 min prior to the MMTT on Day 1 of Periods 1 and 2 in each treatment sequence (1 dose of canagliflozin in Period 1 followed by 1 dose of placebo in Period 2 and then crossover to 1 dose of placebo in Period 1 followed by 1 dose of canagliflozin in Period 2).

Drug: Canagliflozin/Placebo Placebo/Canagliflozin

Interventions

Canagliflozin/Placebo Placebo/Canagliflozin DRUG

Part 2: 240 mL water 20 min prior to the MMTT on Day 1 of Periods 1 and 2 in each treatment sequence (1 dose of canagliflozin in Period 1 followed by 1 dose of placebo in Period 2 and then crossover to 1 dose of placebo in Period 1 followed by 1 dose of canagliflozin in Period 2).

002

no intervention OTHER

Part 1: 240 mL water 10 minutes (min) prior to the start of the MMTT on Day 1 of Periods 1 and 2. Periods 1 and 2 will be separated by 7 to 21 days.

001

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have a Body Mass Index (BMI) between 20 and 27 kg/m2 (inclusive) and a body weight not less than 50 kg
• Be healthy on the basis of physical examination including medical history, vital signs, 12-lead ECG, and all other screening lab tests performed at Screening and Admission
• Agree (if men) to use a double barrier method of birth control (e.g., condom for them and use of spermacide with diaphragm, hormonal contraceptives or intrauterine devices by female partner) during the study and for three months following the last dose of study medication, and to not donate sperm during the study and for 3 months after receiving the last dose of study medication
• Willing/able to adhere to the prohibitions and restrictions specified in this protocol
• Must have signed an informed consent form.

You may not qualify if:

• Have a history of, or currently active, illness or medical condition or disorder that the Investigator considers to be clinically significant
• Has been a smoker or tobacco user within the past 6 months
• Have a history of recent major surgery (within 6 months of study start)
• Tested positive for serology: hepatitis B surface antigen (HBsAg), hepatitis C antibodies (anti-HCV) or human immunodeficiency virus (HIV) antibodies
• Fasting plasma glucose \> 110 mg/dL
• Have a history of alcohol or drug abuse within 2 years prior to Screening or a positive test for alcohol and/or drugs of abuse (including but not limited to barbiturates, opiates, cocaine, cannabinoids, amphetamines,MDMA (Ecstasy) and benzodiazepines) at Screening

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (1)

Unknown Facility

La Jolla, California, United States

Location

Related Publications (1)

• Polidori D, Sha S, Mudaliar S, Ciaraldi TP, Ghosh A, Vaccaro N, Farrell K, Rothenberg P, Henry RR. Canagliflozin lowers postprandial glucose and insulin by delaying intestinal glucose absorption in addition to increasing urinary glucose excretion: results of a randomized, placebo-controlled study. Diabetes Care. 2013 Aug;36(8):2154-61. doi: 10.2337/dc12-2391. Epub 2013 Feb 14.

  PMID: 23412078 DERIVED

MeSH Terms

Interventions

Canagliflozin

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: August 2, 2010
• Study Start: November 1, 2010
• Study Completion: September 1, 2011
• Last Updated: January 2, 2012

Record last verified: 2011-12

Locations

US (1)