AT278 and NovoRapid® in Glucose Clamp Study
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ClinicalTrials.gov Identifier: NCT04660305 |
Recruitment Status :
Completed
First Posted : December 9, 2020
Last Update Posted : July 21, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 1 | Drug: AT278 Drug: NovoRapid | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 38 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Phase 1 Single Dose, Randomised, Double-blind, Two-way Crossover, Glucose Clamp Study Investigating the Pharmacodynamics, Pharmacokinetics and Safety of Arecor Rapid-acting Concentrated Insulin Aspart (AT278) in Comparison to Insulin Aspart NovoRapid® in Participants With Type 1 Diabetes Mellitus (T1DM). |
Actual Study Start Date : | December 2, 2020 |
Actual Primary Completion Date : | June 3, 2021 |
Actual Study Completion Date : | June 11, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: AT278
Single subcutaneous injection 0.3U/kg
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Drug: AT278
Concentrated rapid acting insulin aspart Drug: NovoRapid Rapid acting insulin aspart
Other Name: NovoLog |
Active Comparator: NovoRapid
Single subcutaneous injection 0.3U/kg
|
Drug: AT278
Concentrated rapid acting insulin aspart Drug: NovoRapid Rapid acting insulin aspart
Other Name: NovoLog |
- Area under the glucose infusion-rate curve of insulin aspart [ Time Frame: 0 - 8 hours ]

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of type 1 diabetes for at least 12 months
- Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months
- HbA1c concentration ≤8.5% at screening
- Weight within the range 75kg - 100kg (both inclusive)
Exclusion Criteria:
- Known or suspected hypersensitivity to Investigational Medicinal Products
- Clinically significant concomitant disease or abnormal lab values
- Supine systolic BP outside range 95-140mmHg and/or diastolic BP greater than 90mmHG

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): NCT04660305
Austria | |
Clinical Trials Unit, Medical University of Graz | |
Graz, Austria |
Responsible Party: | Arecor Limited |
ClinicalTrials.gov Identifier: | NCT04660305 |
Other Study ID Numbers: |
ARE-278-102 |
First Posted: | December 9, 2020 Key Record Dates |
Last Update Posted: | July 21, 2021 |
Last Verified: | December 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Autoimmune Diseases Immune System Diseases Insulin Aspart Hypoglycemic Agents Physiological Effects of Drugs |