Drug Trial of Lixisenatide on Gastric Emptying and Blood Pressure Drops in Type 2 Diabetics and Healthy People

NCT02308254 | Unknown Phase 1

• 1 other identifier: 130419
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effects of the drug lixisenatide on blood sugar levels, stomach emptying, blood pressure and heart rate, release of gut hormones and blood flow in the gut after a glucose drink in both healthy subjects and people with type 2 diabetes. If lixisenatide is shown to be effective, it would encourage ongoing evaluation of its potential use in the management of the falls in blood pressure following a meal in diabetic patients.

Conditions

Diabetes Mellitus; Gastroparesis

Keywords

Blood pressure; Gastric emptying; Glycemia; Appetite; Incretin Hormones; Superior mesenteric artery blood low

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  Systolic and diastolic blood pressure (mmHg)

  4.5 hours per study

Secondary Outcomes (3)

• Heart rate

  4.5 hours per study

• Gastric emptying rate

  3 hours per study

• Blood glucose concentration

  3 hours per study

Other Outcomes (6)

• Intragastric distribution

  3 hours per study

• Gastrointestinal hormone release (concentrations of GLP-1, GIP, C-peptide and 3-OMG)

  4.5 hours per study

• Superior mesenteric artery blood flow

  3.5 hours per study

Study Arms (2)

Lixisenatide

ACTIVE COMPARATOR

Lixisenatide: 10 mcg, one subcutaneous injection dose

Drug: Lixisenatide

Placebo

PLACEBO COMPARATOR

Matching placebo: one subcutaneous injection dose

Drug: Placebo

Interventions

Lixisenatide DRUG

Abdominal administration

Also known as: Lyxumia

Lixisenatide

Placebo DRUG

Abdominal administration

Also known as: Dummy

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects:
• Male or female (females using appropriate contraceptive method or willing to undergo pregnancy test)
• Body Mass Index (BMI) 19 - 30 kg/m2
• Type 2 Diabetic Patients:
• As per "healthy subjects"
• Type 2 diabetes (World Health Organisation (WHO) criteria) managed by diet alone or on metformin
• Glycated haemoglobin \>6.0% and \<8.5%

You may not qualify if:

• Subjects with a history of severe respiratory, cardiovascular, hepatic and/or renal disease (severe in that the social or physical manifestations of the disease, or living with the condition, impact negatively and significantly on the individuals' ability to lead a normal day to day life), chronic alcohol abuse or epilepsy (excluded by history) or if iron status, or liver function tests are outside the following ranges:
• Alanine aminotransferase (ALT) 0 - 55 U/L
• Alkaline phosphatase 30 - 110 U/L
• Aspartate transaminase 0 - 45 U/L
• Amylase and/or lipase \>3 x ULN
• Bilirubin 6 - 24 mmol/L
• Ferritin 15 - 200 ng/mL (females); 30 - 300 ng/mL (males)
• Haemoglobin 115 - 155 g/L (females); 135 - 172 g/L (males)
• Subjects with a creatinine clearance cut-off of \<50 ml/min
• Subjects requiring medication likely to influence blood pressure or gastrointestinal function
• Subjects with a past history of gastrointestinal disease, including known gastroparesis, significant upper gastrointestinal symptoms and previous gastric surgery
• Subjects with a past history of unexplained pancreatitis, chronic pancreatitis, pancreatectomy
• Subjects with a current or prior history of c-cell carcinoma
• Smoking \> 10 cigarettes/day
• Alchohol consumption \> 20 g/day

Sponsors & Collaborators

• Royal Adelaide Hospital: lead
• Sanofi: collaborator
• National Health and Medical Research Council, Australia: collaborator

Study Sites (1)

Discipline of Medicine, Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

Related Publications (38)

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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• Rosenstock J, Raccah D, Koranyi L, et al. Efficacy and safety of lixisenatide once daily versus exenatide twice daily in patients with T2DM insufficiently controlled on metformin (GetGoal-X). Poster presented at 47th Annual Meeting of the European Association for the Study of Diabetes, 12-16 September 2011, Lisbon, Portugal. Diabetologia 2011;54(Suppl 1):1-542 (Abstract 786).

  BACKGROUND

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MeSH Terms

Conditions

Diabetes Mellitus; Gastroparesis

Interventions

lixisenatide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen L Jones, PhD

  University of Adelaide, Royal Adelaide Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachael S Tippett, BSc Honours

CONTACT

8222 2915; rachael.tippett@adelaide.edu.au

Laurence G Trahair, BHlthSci Hon

CONTACT

8222 2915; laurence.trahair@adelaide.edu.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: December 4, 2014
• Study Start: November 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 29, 2015

Record last verified: 2015-10

Locations

AU (1)