DiabetesPhase 3NCT02648217

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

A Phase 3 study testing insulin degludec/insulin aspart and biphasic insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 32 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This trial is conducted in Africa and Asia. The aim of this trial is to compare 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: insulin degludec/insulin aspart and biphasic insulin aspart
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 263 participants
Where: 32 sitesin 6 countries
Study dates: 4 Jan 2016to 5 Sep 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, age at least 18 years at the time of signing informed consent. Algeria: Male or female, age at least 19 years at the time of signing informed consent
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

Who cannot join

Any contraindication for successful and sustained fasting from a medical perspective at the discretion of the investigator (such as acute illness, severe hypoglycaemia within 90 days prior to screening (Visit 1), hypoglycaemia unawareness, ketoacidosis within 90 days prior to screening (Visit), hyperosmolar hyperglycaemic coma within 90 days prior to screening (Visit 1), subjects performing intense physical labour)

Trial locations and contacts

32 sites in 6 countries.

Country

City, postcode or hospital

32 sites in 6 countries

India9 sites

Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, 500 001
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, 500058
Novo Nordisk Investigational Site
Kolkata, West Bengal, 700073
Novo Nordisk Investigational Site
Kozhikode, Kerala, 673017
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400010
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400058
Novo Nordisk Investigational Site
Mysore, Karnataka, 570001
Novo Nordisk Investigational Site
New Delhi, 110001
Novo Nordisk Investigational Site
Pune, Maharashtra, 411001

Other trials in India

South Africa9 sites

Novo Nordisk Investigational Site
Benoni, Gauteng, 1501
Novo Nordisk Investigational Site
Cape Town, Western Cape, 7925
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4091
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4092
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4450
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 1812
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 1827
Novo Nordisk Investigational Site
Lenasia, Gauteng, 1827
Novo Nordisk Investigational Site
Pretoria, Gauteng, 0181

Other trials in South Africa

Algeria4 sites

Novo Nordisk Investigational Site
Algiers
Novo Nordisk Investigational Site
Oran, 31000
Novo Nordisk Investigational Site
Sétif, 19000
Novo Nordisk Investigational Site
Sidi Bel Abbes, 22000

Other trials in Algeria

United Arab Emirates4 sites

Novo Nordisk Investigational Site
Ajman, 21499
Novo Nordisk Investigational Site
Ajman, 4184
Novo Nordisk Investigational Site
Dubai, 7272
Novo Nordisk Investigational Site
Umm Al Quwain City, 24

Other trials in United Arab Emirates

Lebanon3 sites

Novo Nordisk Investigational Site
Beirut
Novo Nordisk Investigational Site
Hazmiyeh
Novo Nordisk Investigational Site
Lebanon - Beirut, 9611

Other trials in Lebanon

Malaysia3 sites

Novo Nordisk Investigational Site
Cheras, 56000
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, 16150
Novo Nordisk Investigational Site
Seremban, Negeri Sembilan, 70400

Other trials in Malaysia

About this study

Official title: A Trial 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

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin degludec/insulin aspart, biphasic insulin aspart
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

insulin degludec/insulin aspartDrug
Injected subcutaneously (s.c., under the skin)twice daily. The pre-trial insulin will be discontinued.
biphasic insulin aspartDrug
Injected subcutaneously (s.c., under the skin)twice daily. The pre-trial insulin will be discontinued.

Study groups in NCT02648217
Study group	Role	What they receive
IDegAsp U100 BID	Experimental	Not described Receives: Drug: insulin degludec/insulin aspart
BIAsp U100 BID	Active comparator	Not described Receives: Drug: biphasic insulin aspart

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in HbA1c (%) (Glycosylated Haemoglobin)
Mean change in HbA1c was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan).
Measured: From week 0 to end of Ramadan (day 29 of Ramadan)

Secondary outcomes (6)

Change in Fasting Plasma Glucose (FPG)
Mean change in FPG was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan).
Measured: From week 0 to end of Ramadan (day 29 of Ramadan)
Change in Fructosamine
Mean change in fructosamine was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan).
Measured: From week 0 to end of Ramadan (day 29 of Ramadan)
Number of Subjects Who Achieve HbA1c Below 7% (53 mmol/Mol (American Diabetes Association (ADA) Target )
Number of subjects who achieved HbA1c below 7% (53 mmol/mol; ADA target) at the end of Ramadan (day 29 of Ramadan).
Measured: End of Ramadan (day 29 of Ramadan)
Number of Subjects Who Achieve FPG Below or Equal to 7.2 mmol/L (ADA Target)
Number of subjects who achieved FPG <=7.2 mmol/L at the end of Ramadan (day 29 of Ramadan). The above written (in the endpoint title) 'ADA target' is not applicable for FPG.
Measured: End of Ramadan (day 29 of Ramadan)
Number of Treatment Emergent Hypoglycaemic Episodes Both According to the Novo Nordisk Definition for Hypoglycaemic Episodes (Severe or BG Hypoglycaemia) as Well as According to the ADA definition1 Confirmed Symptomatic
Treatment-emergent hypoglycaemic episodes: If the onset of the episode occurred on or after the first day of investigational medicinal product (IMP; IDegAsp/BIAsp 30) administration, and no later than 1 day after the last day on IMP, before switching to or being treated with another insulin product.
The above mentioned definitions (in endpoint title) should read as the following:
Novo Nordisk definition; severe or blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that was severe according to ADA classification or BG confirmed by a plasma glucose (PG) value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
American Diabetes Association (ADA) definition; documented symptomatic hypoglycaemia: An episode, during which typical symptoms of hypoglycaemia were accompanied by a measured PG concentration ≤3.9 mmol/L (70 mg/dL).
Due to character limitation, severe hypoglycaemia as per ADA classification is not defined here; see next outcome measure.
Measured: From week 0 to 4 weeks post Ramadan
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes, which occurred between 00:01 and 05:59 both inclusive.
Novo Nordisk definition; severe or blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that was severe according to ADA classification or BG confirmed by a plasma glucose (PG) value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Severe hypoglycaemia as per ADA classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.
Measured: From week 0 to 4 weeks post Ramadan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jan 20165 Sep 2016

First posted6 Jan 2016 (estimated)
Study start4 Jan 2016
Primary completion4 Sep 2016
Study completion5 Sep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 263 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02648217
Sponsor's protocol ID: NN5401-4243
Other IDs: U1111-1170-8304
Status last verified: Dec 2017
First submitted: 5 Jan 2016
Last updated: 11 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 29183844
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.
PubMed 37435938
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.
PubMed 35044568

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Trial 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
ClinicalTrials.gov ID: NCT02648217
Acronym / sponsor ID: NN5401-4243
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 263 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 4 Jan 2016 (actual)
Primary completion: 4 Sep 2016 (actual)
Study completion: 5 Sep 2016 (actual)
First posted: 6 Jan 2016 (estimated)
Results: Posted 11 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
IDegAsp U100 BID	Experimental	Drug: insulin degludec/insulin aspart
BIAsp U100 BID	Active comparator	Drug: biphasic insulin aspart

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male or female, age at least 18 years at the time of signing informed consent. Algeria: Male or female, age at least 19 years at the time of signing informed consent
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)

Key exclusion criteria (1 listed)

Any contraindication for successful and sustained fasting from a medical perspective at the discretion of the investigator (such as acute illness, severe hypoglycaemia within 90 days prior to screening (Visit 1), hypoglycaemia unawareness, ketoacidosis within 90 days prior to screening (Visit), hyperosmolar hyperglycaemic coma within 90 days prior to screening (Visit 1), subjects performing intense physical labour)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
insulin degludec/insulin aspartInjected subcutaneously (s.c., under the skin)twice daily. The pre-trial insulin will be discontinued.	Drug	IDegAsp U100 BID
biphasic insulin aspartInjected subcutaneously (s.c., under the skin)twice daily. The pre-trial insulin will be discontinued.	Drug	BIAsp U100 BID

Primary outcome

Change in HbA1c (%) (Glycosylated Haemoglobin)
Time frame: From week 0 to end of Ramadan (day 29 of Ramadan)
Mean change in HbA1c was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan).

6 secondary outcomes

Change in Fasting Plasma Glucose (FPG)
Time frame: From week 0 to end of Ramadan (day 29 of Ramadan)
Change in Fructosamine
Time frame: From week 0 to end of Ramadan (day 29 of Ramadan)
Number of Subjects Who Achieve HbA1c Below 7% (53 mmol/Mol (American Diabetes Association (ADA) Target )
Time frame: End of Ramadan (day 29 of Ramadan)
Number of Subjects Who Achieve FPG Below or Equal to 7.2 mmol/L (ADA Target)
Time frame: End of Ramadan (day 29 of Ramadan)
Number of Treatment Emergent Hypoglycaemic Episodes Both According to the Novo Nordisk Definition for Hypoglycaemic Episodes (Severe or BG Hypoglycaemia) as Well as According to the ADA definition1 Confirmed Symptomatic
Time frame: From week 0 to 4 weeks post Ramadan
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Time frame: From week 0 to 4 weeks post Ramadan

Results and safety

Results posted to the registry on 11 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Insulin Degludec/Insulin Aspart	131	121
Biphasic Insulin Aspart 30	132	127

Primary outcome: Change in HbA1c (%) (Glycosylated Haemoglobin)

Time frame: From week 0 to end of Ramadan (day 29 of Ramadan). Least squares mean (Standard Error). Unit: Percentage (%) of HbA1c

Measure	Insulin Degludec/Insulin Aspart n = 121	Biphasic Insulin Aspart 30 n = 124
Value	-1.11 (0.13)	-1.13 (0.13)

Insulin Degludec/Insulin Aspart vs Biphasic Insulin Aspart 30: Treatment Contrast: 0.02 (95% CI -0.20 to 0.24), p = 0.8426, Mixed model for repeated measurements

Population analysed: Here, 'number of subjects analysed' specifies the number of subjects, who contributed to the analysis.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Insulin Degludec/Insulin Aspart	5 of 130 (3.8%)	54 of 130 (41.5%)	Not reported
Biphasic Insulin Aspart 30	3 of 132 (2.3%)	47 of 132 (35.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 29183844Hassanein 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.
Derived from this study: PubMed 37435938Lee 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.
Derived from this study: PubMed 35044568Yang 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.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

32 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin degludec/insulin aspart and biphasic insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 32 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in India, South Africa, Algeria, United Arab Emirates, Lebanon and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (%) (Glycosylated Haemoglobin) (time frame: From week 0 to end of Ramadan (day 29 of Ramadan)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02648217, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.