Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart Twice Daily and Biphasic Insulin Aspart Twice Daily in Subjects With Type 2 Diabetes Mellitus Before, During and After Ramadan
NCT ID: NCT02648217
Last Updated: 2018-09-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
263 participants
INTERVENTIONAL
2016-01-04
2016-09-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IDegAsp U100 BID
insulin degludec/insulin aspart
Injected subcutaneously (s.c., under the skin)twice daily. The pre-trial insulin will be discontinued.
BIAsp U100 BID
biphasic insulin aspart
Injected subcutaneously (s.c., under the skin)twice daily. The pre-trial insulin will be discontinued.
Interventions
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insulin degludec/insulin aspart
Injected subcutaneously (s.c., under the skin)twice daily. The pre-trial insulin will be discontinued.
biphasic insulin aspart
Injected subcutaneously (s.c., under the skin)twice daily. The pre-trial insulin will be discontinued.
Eligibility Criteria
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Inclusion Criteria
* Subjects diagnosed (clinically) with type 2 diabetes mellitus prior to day of screening (Visit 1)
* Treated with any pre-mix/self-mix or basal insulin regimen for at least 90 days prior to the day of screening (Visit 1)
* Subjects not on any OAD(s) (oral anti-diabetic drug) prior to trial participation OR subjects on fixed daily dose(s) of OAD(s) for at least 90 days prior to screening (Visit 1). The OAD(s) include any of the following anti-diabetic drug(s)/regimen: Biguanides (metformin equal to or above 1500 mg or maximum tolerated dose documented in the subject medical record) Insulin secretagogues (sulfonylureas (SU) and glinides), Dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors), a-glucosidase inhibitors, Sodium-glucose co-transporter 2- inhibitors (SGLT2 Inhibitors ) (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record)
* HbA1c 7.0%-10.0% (53-86 mmol/mol) (both inclusive, by central laboratory analysis)
* Intention to fast (daytime, i.e., between dawn and sunset) during Ramadan after receiving medical counselling regarding the risk of fasting
* Willing to give blood during Ramadan
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Algiers, , Algeria
Novo Nordisk Investigational Site
Oran, , Algeria
Novo Nordisk Investigational Site
Sétif, , Algeria
Novo Nordisk Investigational Site
Sidi Bel Abbes, , Algeria
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India
Novo Nordisk Investigational Site
Mysore, Karnataka, India
Novo Nordisk Investigational Site
Kozhikode, Kerala, India
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India
Novo Nordisk Investigational Site
Pune, Maharashtra, India
Novo Nordisk Investigational Site
Kolkata, West Bengal, India
Novo Nordisk Investigational Site
New Delhi, , India
Novo Nordisk Investigational Site
Beirut, , Lebanon
Novo Nordisk Investigational Site
Hazmiyeh, , Lebanon
Novo Nordisk Investigational Site
Lebanon - Beirut, , Lebanon
Novo Nordisk Investigational Site
Cheras, , Malaysia
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, , Malaysia
Novo Nordisk Investigational Site
Seremban, Negeri Sembilan, , Malaysia
Novo Nordisk Investigational Site
Benoni, Gauteng, South Africa
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa
Novo Nordisk Investigational Site
Lenasia, Gauteng, South Africa
Novo Nordisk Investigational Site
Pretoria, Gauteng, South Africa
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa
Novo Nordisk Investigational Site
Ajman, , United Arab Emirates
Novo Nordisk Investigational Site
Ajman, , United Arab Emirates
Novo Nordisk Investigational Site
Dubai, , United Arab Emirates
Novo Nordisk Investigational Site
Umm Al Quwain City, , United Arab Emirates
Countries
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References
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Hassanein M, Echtay AS, Malek R, Omar M, Shaikh SS, Ekelund M, Kaplan K, Kamaruddin NA. Original paper: Efficacy and safety analysis of insulin degludec/insulin aspart compared with biphasic insulin aspart 30: A phase 3, multicentre, international, open-label, randomised, treat-to-target trial in patients with type 2 diabetes fasting during Ramadan. Diabetes Res Clin Pract. 2018 Jan;135:218-226. doi: 10.1016/j.diabres.2017.11.027. Epub 2017 Nov 26.
Lee SWH, Chen WS, Sellappans R, Md Sharif SB, Metzendorf MI, Lai NM. Interventions for people with type 2 diabetes mellitus fasting during Ramadan. Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD013178. doi: 10.1002/14651858.CD013178.pub2.
Yang W, Akhtar S, Franek E, Haluzik M, Hirose T, Kalyanam B, Kar S, Wu T, Gogas Yavuz D, Unnikrishnan AG. Postprandial Glucose Excursions in Asian Versus Non-Asian Patients with Type 2 Diabetes: A Post Hoc Analysis of Baseline Data from Phase 3 Randomised Controlled Trials of IDegAsp. Diabetes Ther. 2022 Feb;13(2):311-323. doi: 10.1007/s13300-021-01196-7. Epub 2022 Jan 19.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1170-8304
Identifier Type: OTHER
Identifier Source: secondary_id
NN5401-4243
Identifier Type: -
Identifier Source: org_study_id
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