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A Research Study of How Different Amounts of a New Medicine NNC0148-0287 C (Insulin 287) Works on the Blood Sugar of People Who Are Japanese With Type 1 Diabetes When Given Once a Week

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ClinicalTrials.gov Identifier: NCT03766854
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study will look at how insulin 287 works, if it is safe and the side effects in people who are Japanese with type 1 diabetes. The study will test how insulin goes through your blood, how long it stays there and how the blood sugar is lowered. Insulin 287 is a new medicine. Insulin glargine is already approved to treat diabetes. The study doctors can prescribe insulin glargine. The participants will get both of the insulins in a random order. The participants 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 7 weeks when the participants inject insulin glargine every day before they start insulin 287 period or insulin glargine period. All doses will be injected under the skin. During the run-in period, the participants adjust the insulin glargine dose and make their blood sugar levels stable. From the run-in period, the participants will take insulin aspart as bolus insulin. The study will last for about 16 - 28 weeks. The participants will have 24 visits with the study doctor. There will be 3 glucose clamps where the participants' blood sugar is tested over time. The participants cannot be in the study if the study doctor thinks that there are risks for their health.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Insulin 287 Drug: Insulin glargine U100 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multiple-dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0287 C (Insulin 287) for Subcutaneous Administration in Japanese Subjects With Type 1 Diabetes
Actual Study Start Date : December 7, 2018
Estimated Primary Completion Date : December 13, 2019
Estimated Study Completion Date : December 13, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Insulin 287 followed by insulin glargine U100

Run-in period (2 days to 7 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 (PK) 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.

Drug: Insulin 287
Participants will receive subcutaneous (s.c.) injections of insulin 287 once weekly for 8 weeks

Drug: Insulin glargine U100
Participants will receive s.c. injections of insulin glargine once weekly for 2 weeks

Experimental: Insulin glargine U100 followed by insulin 287

Run-in period (2 days to 7 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 OW for 8 weeks and subsequent 4 weeks of terminal PK sampling.

Drug: Insulin 287
Participants will receive subcutaneous (s.c.) injections of insulin 287 once weekly for 8 weeks

Drug: Insulin glargine U100
Participants will receive s.c. injections of insulin glargine once weekly for 2 weeks




Primary Outcome Measures :
  1. AUCI287τ,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


Secondary Outcome Measures :
  1. 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

  2. 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) excluding clamp days ]
    Number of episodes

  3. Change in antiinsulin 287 antibody level [ Time Frame: From first insulin 287 administration (day 1) to follow-up visit (day 106) ]
    Measured in % B/T (percentage of bound tracer measured after precipitation to total tracer)

  4. Change in antiinsulin 287 antibody titres [ Time Frame: From first insulin 287 administration (day 1) to follow-up visit (day 106) ]

    Number of dilutions.

    The antibody titer is calculated by diluting the blood serum sample containing antibody in serial ratios (1:2, 1:4, 1:8, 1:16... and so on). Using an appropriate detection method (e.g., colorimetric, chromatographic, etc.), each dilution is tested for the presence of detectable levels of antibody. The assigned titer value is indicative of the last dilution in which the antibody was detected.


  5. Positive cross-reactive anti-human insulin antibodies [ Time Frame: At follow-up visit (day 106) ]
    Yes/no. Number of participants who developed/not developed positive cross-reactive anti-human insulin antibodies.

  6. AUCI287,0-168,FD - 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

  7. tmax,I287,FD - 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

  8. Cmax,I287,FD - 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

  9. tmax,I287,SS - 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

  10. Cmax,I287,SS - 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

  11. t1/2,I287,SS - 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

  12. CI287,trough - Serum insulin 287 trough concentration [ Time Frame: Measured at the end of each dosing interval 168 hours after dosing (day 8, 15, 22, 29, 36, 43, 50 and 57) ]
    Measured in pmol/L

  13. AUCIGlar,τ,SS - Area under the serum IGlar 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

  14. Cmax,IGlar,SS - Maximum observed serum IGlar concentration at steady state [ Time Frame: From 0 to 24 hours after trial product administration (day 14) ]
    Measured in pmol/L

  15. tmax,IGlar,SS - Time to maximum observed serum IGlar concentration at steady state [ Time Frame: From 0 to 24 hours from trial product administration (day 14) ]
    Measured in hours

  16. CIGlar,trough - Serum IGlar trough concentration [ Time Frame: Measured at the end of each dosing interval 24 hours after trial product administration (day 7, 14 and 15) ]
    Measured in pmol/L

  17. AUCGIR,24-48h,SS - Area under the glucose infusion rate-time curve at steady state [ Time Frame: From 24 to 48 hours after trial product administration (day 51) ]
    Measured in mg/kg

  18. GIRmax,24-48h, SS - Maximum observed glucose infusion rate at steady state [ Time Frame: From 24 to 48 hours after trial product administration (day 51) ]
    Measured in mg/(kg*min)

  19. AUCGIR,150-168h,SS - Area under the glucose infusion rate-time curve at steady state [ Time Frame: From 150 to 168 hours after trial product administration (day 57) ]
    Measured in mg/kg

  20. GIRmax,150-168h,SS - Maximum observed glucose infusion rate at steady state [ Time Frame: From 150 to 168 hours after trial product administration (day 57) ]
    Measured in mg/(kg*min)

  21. AUCGIR,0-24h,SS - 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

  22. GIRmax,0-24h,SS - 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, Japanese subjects, aged 20 - 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 28.0 kg/m^2 (both inclusive).
  • HbA1c less than or equal to 8.0%.

Exclusion Criteria:

  • History or presence of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal or endocrinological conditions (except conditions associated with diabetes mellitus).
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods.
  • Known or suspected hypersensitivity to trial products or related products

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766854


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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Japan
Novo Nordisk Investigational Site Recruiting
Fukuoka, Japan, 812-0025
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03766854     History of Changes
Other Study ID Numbers: NN1436-4422
U1111-1211-7635 ( Other Identifier: World Health Organization (WHO) )
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemic Agents
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Physiological Effects of Drugs