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Trial record 1 of 1 for:    NCT03723772
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A Research Study of How Different Doses of a New Medicine NNC0148-0287 C (Insulin 287) Work on the Blood Sugar in People With Type 1 Diabetes When it is Taken Once a Week

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03723772
Recruitment Status : Completed
First Posted : October 30, 2018
Last Update Posted : July 13, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE October 26, 2018
First Posted Date  ICMJE October 30, 2018
Last Update Posted Date July 13, 2020
Actual Study Start Date  ICMJE November 29, 2018
Actual Primary Completion Date June 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2018)
AUCI287,τ,SS - Area under the serum insulin 287 concentration-time curve during one dosing interval at steady state [ Time Frame: From 0 to 168 hours after trial product administration (Day 50) ]
Measured in pmol*h/L
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • AUCGIR,16-52h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state [ Time Frame: From 16 to 52 hours after trial product administration (Day 50) ]
    Measured in mg/kg
  • AUCGIR,138-168h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state [ Time Frame: From 138 to 168 hours after trial product administration (Day 50) ]
    Measured in mg/kg
  • GIRmax,16-52h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state [ Time Frame: From 16 to 52 hours after trial product administration (Day 50) ]
    Measured in mg/(kg*min)
  • GIRmax,138-168h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state [ Time Frame: From 138 to 168 hours after trial product administration (Day 50) ]
    Measured in mg/(kg*min)
  • AUCGIR,0-24h,SS (for insulin glargine) - Area under the glucose infusion rate-time curve at steady state [ Time Frame: From 0 to 24 hours after trial product administration (Day 14) ]
    Measured in mg/kg
  • GIRmax,0-24h, SS (for insulin glargine) - Maximum observed glucose infusion rate at steady state [ Time Frame: From 0 to 24 hours after trial product administration (Day 14) ]
    Measured in mg/(kg*min)
  • AUCI287,0-168h,FD (from insulin 287) - Area under the serum insulin 287 concentration-time curve after the first dose [ Time Frame: From 0 to 168 hours after trial product administration (Day 1) ]
    Measured in pmol*h/L
  • Cmax,I287,FD (for insulin 287) - Maximum observed serum insulin 287 concentration after the first dose [ Time Frame: From 0 to 168 hours after trial product administration (Day 1) ]
    Measured in pmol/L
  • tmax,I287,FD (for insulin 287) - Time to maximum observed serum insulin 287 concentration after the first dose [ Time Frame: From 0 to 168 hours after trial product administration (Day 1) ]
    Measured in hours
  • Cmax,I287,SS (for insulin 287) - Maximum observed serum insulin 287 concentration after the last dose [ Time Frame: From 0 to 168 hours after trial product administration (Day 50) ]
    Measured in pmol/L
  • tmax,I287,SS (for insulin 287) - Time to maximum observed serum insulin 287 concentration after the last dose [ Time Frame: From 0 to 168 hours after trial product administration (Day 50) ]
    Measured in hours
  • t½,I287,SS (for insulin 287) - Terminal half-life for insulin 287 at steady state [ Time Frame: Terminal part of the serum insulin 287 concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after last trial product administration (Day 50) ]
    Measured in hours
  • CI287,trough (for insulin 287) - Serum insulin 287 trough concentration [ Time Frame: Measured at the end of each dosing interval 168 hours after trial product administration (Day 8, 15, 22, 29, 36, 43, 50 and 57) ]
    Measured in pmol/L
  • AUCIGlar,τ,SS (for insulin glargine) - Area under the serum insulin glargine concentration-time curve during one dosing interval at steady state [ Time Frame: From 0 to 24 hours after trial product administration (Day 14) ]
    Measured in pmol*h/L
  • Cmax,IGlar,SS (for insulin glargine) - Maximum observed serum insulin glargine concentration at steady state [ Time Frame: From 0 to 24 hours after trial product administration (Day 14) ]
    Measured in pmol/L
  • tmax,IGlar,SS (for insulin glargine) - Time to maximum observed serum insulin glargine concentration at steady state [ Time Frame: From 0 to 24 hours after trial product administration (Day 14) ]
    Measured in hours
  • CIGlar,trough (for insulin glargine) - Serum insulin glargine trough concentration [ Time Frame: Measured at the end of each dosing interval 24 hours after trial product administration (Day 4, 7, 14 and 15) ]
    Measured in pmol/L
  • Number of adverse events (AEs) [ Time Frame: From first trial product administration (Day 1) to end of last dosing interval (Day 57 for insulin 287, day 15 for IGlar) ]
    Number of events
  • Number of hypoglycaemic episodes [ Time Frame: From first trial product administration (Day 1) to end of last dosing interval (Day 57 for insulin 287, day 15 for IGlar) ]
    Number of episodes
  • Change in anti-insulin 287 antibody level [ Time Frame: From first insulin 287 administration (Day 1) to Follow-up visit (visit 25, day 106) ]
    Measured in % B/T (percentage of bound tracer measured after precipitation to total tracer)
  • Change in anti-insulin 287 antibody titres [ Time Frame: From first insulin 287 administration (Day 1) to Follow-up visit (visit 25, day 106) ]
    Number of dilutions
  • Positive cross-reactive anti-human insulin antibodies [ Time Frame: At the follow-up visit (Visit 25, day 106) ]
    Number of patients with/without positive cross-reactive anti-human insulin antibodies
Original Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2018)
  • AUCGIR,16-52h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state [ Time Frame: From 16 to 52 hours after trial product administration (Day 50) ]
    Measured in mg/kg
  • AUCGIR,138-168h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state [ Time Frame: From 138 to 168 hours after trial product administration (Day 50) ]
    Measured in mg/kg
  • GIRmax,16-52h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state [ Time Frame: From 16 to 52 hours after trial product administration (Day 50) ]
    Measured in mg/(kg*min)
  • GIRmax,138-168h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state [ Time Frame: From 138 to 168 hours after trial product administration (Day 50) ]
    Measured in mg/(kg*min)
  • AUCGIR,0-24h,SS (for insulin glargine) - Area under the glucose infusion rate-time curve at steady state [ Time Frame: From 0 to 24 hours after trial product administration (Day 14) ]
    Measured in mg/kg
  • GIRmax,0-24h, SS (for insulin glargine) - Maximum observed glucose infusion rate at steady state [ Time Frame: From 0 to 24 hours after trial product administration (Day 14) ]
    Measured in mg/(kg*min)
  • AUCI287,0-168h,FD (from insulin 287) - Area under the serum insulin 287 concentration-time curve after the first dose [ Time Frame: From 0 to 168 hours after trial product administration (Day 1) ]
    Measured in pmol*h/L
  • Cmax,I287,FD (for insulin 287) - Maximum observed serum insulin 287 concentration after the first dose [ Time Frame: From 0 to 168 hours after trial product administration (Day 1) ]
    Measured in pmol/L
  • tmax,I287,FD (for insulin 287) - Time to maximum observed serum insulin 287 concentration after the first dose [ Time Frame: From 0 to 168 hours after trial product administration (Day 1) ]
    Measured in hours
  • Cmax,I287,SS (for insulin 287) - Maximum observed serum insulin 287 concentration after the last dose [ Time Frame: From 0 to 168 hours after trial product administration (Day 50) ]
    Measured in pmol/L
  • tmax,I287,SS (for insulin 287) - Time to maximum observed serum insulin 287 concentration after the last dose [ Time Frame: From 0 to 168 hours after trial product administration (Day 50) ]
    Measured in hours
  • t½,I287,SS (for insulin 287) - Terminal half-life for insulin 287 at steady state [ Time Frame: Terminal part of the serum insulin 287 concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after last trial product administration (Day 50) ]
    Measured in hours
  • CI287,trough (for insulin 287) - Serum insulin 287 trough concentration [ Time Frame: Measured at the end of each dosing interval 168 hours after trial product administration (Day 8, 15, 22, 29, 36, 43, 50 and 57) ]
    Measured in pmol/L
  • AUCIGlar,τ,SS (for insulin glargine) - Area under the serum insulin glargine concentration-time curve during one dosing interval at steady state [ Time Frame: From 0 to 24 hours after trial product administration (Day 14) ]
    Measured in pmol*h/L
  • Cmax,IGlar,SS (for insulin glargine) - Maximum observed serum insulin glargine concentration at steady state [ Time Frame: From 0 to 24 hours after trial product administration (Day 14) ]
    Measured in pmol/L
  • tmax,IGlar,SS (for insulin glargine) - Time to maximum observed serum insulin glargine concentration at steady state [ Time Frame: From 0 to 24 hours after trial product administration (Day 14) ]
    Measured in hours
  • CIGlar,trough (for insulin glargine) - Serum insulin glargine trough concentration [ Time Frame: Measured at the end of each dosing interval 24 hours after trial product administration (Day 4, 7, 14 and 15) ]
    Measured in pmol/L
  • Number of adverse events (AEs) [ Time Frame: From first trial product administration (Day 1) to end of last dosing interval (Day 57 for insulin 287, day 15 for IGlar) ]
    Number of events
  • Number of hypoglycaemic episodes [ Time Frame: From first trial product administration (Day 1) to end of last dosing interval (Day 57 for insulin 287, day 15 for IGlar) ]
    Number of episodes
  • Change in anti-insulin 287 antibody level [ Time Frame: From first insulin 287 administration (Day 1) to Follow-up visit (visit 26) ]
    Measured in % B/T (percentage of bound tracer measured after precipitation to total tracer)
  • Change in anti-insulin 287 antibody titres [ Time Frame: From first insulin 287 administration (Day 1) to Follow-up visit (visit 26) ]
    Number of dilutions
  • Positive cross-reactive anti-human insulin antibodies [ Time Frame: At the follow-up visit (Visit 26, day 106) ]
    Number of patients with/without positive cross-reactive anti-human insulin antibodies
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Research Study of How Different Doses of a New Medicine NNC0148-0287 C (Insulin 287) Work on the Blood Sugar in People With Type 1 Diabetes When it is Taken Once a Week
Official Title  ICMJE A Trial Investigating the Pharmacokinetics and Pharmacodynamics of NNC0148-0287 C(Insulin 287) at Steady State Conditions in Subjects With Type 1 Diabetes
Brief Summary This study compares the new long-acting insulin 287 with the marketed insulin glargine for use in type 1 diabetes. The study will test how insulin is taken up in your blood, how long it stays there and how the blood sugar is lowered. The participant will get both of the insulins in a random order. Insulin 287 is a new medicine while insulin glargine is already approved for the treatment of diabetes and can be prescribed by a doctor. The participant will get 8 weekly doses of insulin 287 and 14 daily doses of insulin glargine. There will also be a run-in period of 2 days to 4 weeks with daily doses of insulin glargine before you start the insulin 287 period. All doses will be injected under the skin. The study will last for about 16 to 24 weeks. The participant will have 27 visits with the study doctor.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 1
Intervention  ICMJE
  • Drug: Insulin 287
    Participants will receive subcutaneous injections of insulin 287 once weekly for 8 weeks
  • Drug: IGlar U100
    Participants will receive subcutaneous injections of insulin glargine once weekly for 2 weeks.
Study Arms  ICMJE
  • Experimental: Insulin 287 followed by insulin glargine U100

    Run-in period (2 days to 4 weeks): The basal insulin glargine dose for each subject will be established and optimised.

    After run-in, participants will receive insulin 287 once a week (OW) for 8 weeks and subsequent 4 weeks of terminal pharmacokinetic sampling where subjects are treated with once daily (OD) insulin glargine.

    After insulin 287 treatment, participants will receive insulin glargine U100 OD for 2 weeks.

    Interventions:
    • Drug: Insulin 287
    • Drug: IGlar U100
  • Experimental: Insulin glargine U100 followed by insulin 287

    Run-in period (2 days to 4 weeks): The basal insulin glargine dose for each subject will be established and optimised.

    After run-in, participants will receive insulin glargine U100 OD for 2 weeks followed by 1-14 days (at least 1 day is mandatory) of continued insulin glargine treatment.

    After insulin glargine treatment, participants will receive insulin 287 once a week (OW) for 8 weeks and subsequent 4 weeks of terminal pharmacokinetic sampling.

    Interventions:
    • Drug: Insulin 287
    • Drug: IGlar U100
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 26, 2018)
66
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 26, 2020
Actual Primary Completion Date June 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent
  • Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening
  • Current daily basal insulin treatment greater than or equal to 0.2 U/kg/day
  • Body mass index between 18.5 and 29.0 kg/m^2 (both inclusive)
  • HbA1c less than or equal to 9.0%

Exclusion Criteria:

  • History or presence of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal or endocrinological conditions. Subjects with complications associated to diabetes can be included only if they are judged to be mild by the investigator. Subjects with other comorbidities (e.g. dyslipidaemia, hypertension and hypothyroidism) can be included if they have a stable treatment and are in adequate control according to the judgement of the investigator- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
  • Known or suspected hypersensitivity to trial products or related products
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03723772
Other Study ID Numbers  ICMJE NN1436-4225
U1111-1204-8909 ( Other Identifier: World Health Organization (WHO) )
2017-004528-31 ( Registry Identifier: European Medicines Agency (EudraCT) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP