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Trial · Interventional

CompletedPhase 1Registry data

Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects and Male Subjects With Type 2 Diabetes

NCTNCT01686945 (opens ClinicalTrials.gov in a new tab)Other idNN9924-3991Other id2012-000361-20Other idU1111-1127-4408

Overview

Status
Completed
Phase
Phase 1
Enrollment
107 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

Germany

Start
19 Sept 2012
Primary completion
8 Apr 2013
Completion
8 Apr 2013
First posted
18 Sept 2012 (estimated)
Last update posted
4 Jan 2019
Conditions
Diabetes · Diabetes Mellitus, Type 2 · Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014
  1. Ph 1

    Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects and Male Subjects With Type 2 Diabetes

    NCT01686945

    19 Sept 2012 to 8 Apr 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body), and pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a long-acting GLP-1 analogue (oral semaglutide) and a carrier in healthy male subjects and male subjects with type 2 diabetes (T2D).

Interventions

  • semaglutideDrug
  • semaglutideDrug
  • semaglutideDrug
  • placeboDrug
  • placeboDrug

Arms4

  • Experimental

    Healthy - 20 mg

  • Experimental

    Healthy - 40 mg

  • Experimental

    Healthy - 60 mg

  • Experimental

    T2D - 20/40/60 mg

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of treatment emergent adverse events (TEAEs) recorded

    Time frame · From the time of first dosing and until completion of the post treatment follow-up visits (Day 90 to 104)

Secondary outcomes(6)
  1. Area under the plasma concentration curve over the dosing interval (0-24 hours)

    Time frame · After the last 3 daily doses for semaglutide and carrier

  2. Change from baseline in fasting plasma glucose (FPG)

    Time frame · Week 0, week 10 (Day 69)

  3. Change from baseline in C-peptide

    Time frame · Week 0, week 10 (Day 69)

  4. Change from baseline in insulin

    Time frame · Week 0, week 10 (Day 69)

  5. Change from baseline in glucagon

    Time frame · Week 0, week 10 (Day 69)

  6. Change from baseline in glycosylated haemoglobin type A1c (HbA1c)

    Time frame · Week 0, week 10 (Day 69)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2019

6 results

Safety and Pharmacokinetics of Single and Multiple Ascending Doses of the Novel Oral Human GLP-1 Analogue, Oral Semaglutide, in Healthy Subjects and Subjects with Type 2 Diabetes.

Granhall et al. 2019Clinical pharmacokineticscited by 130

PMID 30565096DOI 10.1007/s40262-018-0728-4PUB-30565096

Free to read · publisher termsCC BY-NC6 results

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultSeco A, Aparicio S, Gonzalez-Camejo J, Jimenez-Benitez A, Mateo O, Mora JF, Noriega-Hevia G, Sanchis-Perucho P, Serna-Garcia R, Zamorano-Lopez N, Gimenez JB, Ruiz-Martinez A, Aguado D, Barat R, Borras L, Bouzas A, Marti N, Paches M, Ribes J, Robles A, Ruano MV, Serralta J, Ferrer J. Resource recovery from sulphate-rich sewage through an innovative anaerobic-based water resource recovery facility (WRRF). Water Sci Technol. 2018 Dec;78(9):1925-1936. doi: 10.2166/wst.2018.492. PMID 30566096

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 64 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and laboratory safety tests performed during the screening visit, as judged by the investigator. This also applies to subjects with T2D, except for the underlying diabetes with or without associated hyperlipidaemia and/or hypertension * Body mass index (BMI): a) Healthy subjects: above or equal to 20 and below 30 kg/m\^2. b) Subjects with T2D: BMI above or equal to 20 and below or equal to 37 kg/m\^2 * Glycosylated haemoglobin (HbA1c): a) Healthy subjects: below 6.0%. b) Subjects with T2D: between 6.5 and 9.0% (both inclusive) * Additional inclusion criterion only for subjects with T2D: Male subjects with T2D (diagnosed within the past 10 years) treated with diet and exercise and/or who have been on stable doses of metformin for at least 12 weeks prior to Visit 3 (Day -1 or 0) and for whom no changes in treatment are planned for the trial period Exclusion Criteria: * History of, or presence of, cancer, diabetes (only for healthy subjects) or any clinically significant cardiovascular (only for healthy subjects), respiratory, metabolic, renal, hepatic, gastro-intestinal (GI), endocrinological (except diabetes in subjects with T2D), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator * Blood pressure in supine position at the screening examination above: a) 140 mmHg systolic and/or above 90 mmHg diastolic for healthy subjects. b) 160 mmHg systolic and/or above 95 mmHg diastolic for subjects with T2D * Use of prescription or non-prescription medicinal products (except routine vitamins) within three weeks preceding the dosing. Occasional use of paracetamol or acetylsalicylic acid is permitted. a. For subjects with T2D: Any other current diabetes treatment apart from metformin (e.g. treatment with incretin mimetics, Dipeptidyl Peptidase-IV (DPP-IV) inhibitors, insulin secretagogues, insulin or thiazolidinediones (TZDs)). Use of blood lipidregulating agents, as well as blood pressure regulating, and thrombo-embolic agents is allowed * Exclusion criteria only for subjects with T2D: * Proliferative retinopathy or maculopathy requiring acute treatment as determined by funduscopy/fundus photography and judged by the investigator. If subject presents a medical certificate for funduscopy/fundus photography performed within last 3 months this can substitute the funduscopy/fundus photography at screening * Nephropathy stages 3 to 5, i.e. estimated glomerular filtration rate (eGFR) below 60. The eGFRshould be determined using the Modification of Diet in Renal Disease 4-variable method encompassing creatinine, age, gender, and race * Diabetic peripheral neuropathy using the 10 g Semmes-Weinstein monofilament examination at the great toe or plantar aspect of the fifth metatarsal * Clinically significant active cardiovascular disease including history of myocardial infarction and/or heart failure (New York Heart Association (NYHA) class III and IV1) at the discretion of the investigator

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