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NCT Number: NCT02739906

A Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With T1DM

This is a 2 centres, randomised, double blind, three-treatment, three-period cross-over trial in subjects with type 1 diabetes mellitus.

Each subject will be administered individualised single subcutaneous doses of BioChaperone Human Insulin (HinsBet®), insulin lispro (Humalog®) and regular human insulin (Huminsulin® Normal) immediately before ingesting a standardised mixed meal.

Following trial drug administration, PK and PD assessments will be carried until 6 hours after start of the standardized test meal.

The total trial duration for an individual subject will be up to 11 weeks.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Profil Mainz GmbH & Co.KG, Mainz, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subject aged 18-64 years (both inclusive).
  • Type 1 diabetes mellitus (as diagnosed clinically) >= 12 months.
  • Treated with multiple daily insulin injections or CSII >= 12 months.
  • Current total daily insulin treatment < 1.2 (I)U/kg/day.
  • Current total daily bolus insulin treatment < 0.7 (I)U/kg/day.
  • BMI 18.5-28.0 kg/m^2 (both inclusive).
  • HbA1c <= 9.0 % by local laboratory analysis
  • Fasting C-peptide <= 0.30 nmol/L.

Exclusion criteria

  • Known or suspected hypersensitivity to IMPs or related products.
  • Type 2 diabetes mellitus.
  • Previous participation in this trial. Participation is defined as randomised.
  • Participation in any clinical trial within 3 months prior to this trial.
  • Clinically significant abnormal haematology, coagulation, biochemistry, lipids, or urinalysis screening tests, as judged by the Investigator considering the underlying disease.
  • Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator.
  • Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the Investigator might change gastrointestinal motility and food absorption.
  • Unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial.
  • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective contraceptive methods

Treatment and study plan

BioChaperone Human Insulin (HinsBet®)

Drug

BioChaperone Human Insulin (HinsBet®) individualised single subcutaneous injection followed by test meal intake

Insulin Lispro (Humalog®)

Drug

Insulin Lispro (Humalog®) individualised single subcutaneous injection followed by test meal intake

Regular human insulin (Huminsulin® Normal)

Drug

Regular human insulin (Huminsulin® Normal) individualised single subcutaneous injection followed by test meal intake

Primary outcomes

  1. BG1h

    Time frame: 1 hour

    Blood glucose (BG) concentration 1 hour after start of intake of a standardised meal

Secondary outcomes

  1. ΔBG1h

    Time frame: 1 hour

    Mean change from baseline of blood glucose concentration 1 hour after start of intake of a standardised meal

  2. AUCBG,0-1h

    Time frame: 1 hour

    Area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal

  3. ΔAUCBG,0-1h

    Time frame: 1 hour

    Incremental area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal

  4. AUCIns,0-1h

    Time frame: 1 hour

    Area under the serum insulin concentration-time curve from 0-1 hour

  5. Adverse Events

    Time frame: Up to 11 weeks

    Number of Adverse Events

  6. Local tolerability (Number of injection site reactions)

    Time frame: Up to 11 weeks

    Number of injection site reactions

Sponsors and collaborators

Lead sponsor

Adocia

Industry

Registry information

Official study title

A Randomised, Double Blind, Three-period Cross-over Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With Type 1 Diabetes Mellitus (T1DM)

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 15, 2016
Registry last updated
Aug 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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