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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1111-7084 | Other Identifier | WHO | |
| 2008-005771-10 | EudraCT Number |
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This trial is conducted in Africa, Asia, Europe and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg) with insulin glargine (IGlar) in patients with type 2 diabetes. Subjects treated with oral antidiabetic drug(s) (OAD(s)) should continue their current OAD treatment at the stable, prerandomisation dose level and dosing frequency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDeg OD FF | Experimental |
| |
| IDeg OD | Experimental |
| |
| IGlar OD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Injected s.c. (under the skin) once daily (alternative regimen). Dose was individually adjusted. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) | Change from baseline in HbA1c after 26 weeks of treatment | Week 0, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) | Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, before bedtime, at 4 am and before breakfast. | Week 26 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Buenos Aires | B1636DSU | Argentina | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23130654 | Result | Ratner RE, Gough SC, Mathieu C, Del Prato S, Bode B, Mersebach H, Endahl L, Zinman B. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab. 2013 Feb;15(2):175-84. doi: 10.1111/dom.12032. Epub 2012 Dec 3. | |
| 24170235 | Result |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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The trial was conducted at 69 sites in 14 countries: Hungary (3 sites), Macedonia (1 site), Serbia (3 sites), Finland (7 sites), Norway (6 sites), United Kingdom (6 sites), Argentina (4 sites), Mexico (2 sites), South Africa (3 sites), India (10 sites), Malaysia (5 sites), Taiwan (3 sites), Russian Federation (8 sites) and Israel (8 sites).
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| ID | Title | Description |
|---|---|---|
| FG000 | IDeg OD FF | Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses). |
| FG001 | IDeg OD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| insulin degludec | Drug | Injected s.c. (under the skin) once daily. Dose was individually adjusted. |
|
| insulin glargine | Drug | Insulin glargine injected s.c. (under the skin) once daily. Dose was individually adjusted. |
|
| Rate of Confirmed Hypoglycaemic Episodes |
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. |
| Week 0 to Week 26 + 7 days follow up |
| Rate of Nocturnal Confirmed Hypoglycaemic Episodes | Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m. | Week 0 to Week 26 + 7 days follow up |
| Buenos Aires |
| C1425AGC |
| Argentina |
| Novo Nordisk Investigational Site | Ciudad Autónoma de Bs As | C1426ABP | Argentina |
| Novo Nordisk Investigational Site | Rosario | 2000 | Argentina |
| Novo Nordisk Investigational Site | Hanko | 10900 | Finland |
| Novo Nordisk Investigational Site | Harjavalta | FI-29200 | Finland |
| Novo Nordisk Investigational Site | Oulu | 90029 | Finland |
| Novo Nordisk Investigational Site | Tampere | FI-33520 | Finland |
| Novo Nordisk Investigational Site | Turku | 20520 | Finland |
| Novo Nordisk Investigational Site | Turku | FI-20100 | Finland |
| Novo Nordisk Investigational Site | Vantaa | FIN-01600 | Finland |
| Novo Nordisk Investigational Site | Budapest | 1041 | Hungary |
| Novo Nordisk Investigational Site | Debrecen | 4043 | Hungary |
| Novo Nordisk Investigational Site | Győr | 9024 | Hungary |
| Novo Nordisk Investigational Site | Szombathely | H-9700 | Hungary |
| Novo Nordisk Investigational Site | Hyderabad | Andhra Pradesh | 500082 | India |
| Novo Nordisk Investigational Site | Kochi | Kerala | 682041 | India |
| Novo Nordisk Investigational Site | Indore | Madhya Pradesh | 452010 | India |
| Novo Nordisk Investigational Site | Mumbai | Maharashtra | 400012 | India |
| Novo Nordisk Investigational Site | New Dehli | New Delhi | 110029 | India |
| Novo Nordisk Investigational Site | Chandigarh | Punjab | 160012 | India |
| Novo Nordisk Investigational Site | Vellore | Tamil Nadu | 632004 | India |
| Novo Nordisk Investigational Site | Kolkata | West Bengal | 700020 | India |
| Novo Nordisk Investigational Site | Kolkata | West Bengal | 700038 | India |
| Novo Nordisk Investigational Site | Chennai | 600020 | India |
| Novo Nordisk Investigational Site | Hyderabad | 600034 | India |
| Novo Nordisk Investigational Site | Beersheba | 84101 | Israel |
| Novo Nordisk Investigational Site | Haifa | 31096 | Israel |
| Novo Nordisk Investigational Site | Holon | 58100 | Israel |
| Novo Nordisk Investigational Site | Jerusalem | 91120 | Israel |
| Novo Nordisk Investigational Site | Kfar Saba | 44281 | Israel |
| Novo Nordisk Investigational Site | Netanya | 42449 | Israel |
| Novo Nordisk Investigational Site | Petah Tikva | 49100 | Israel |
| Novo Nordisk Investigational Site | Rehovot | 76100 | Israel |
| Novo Nordisk Investigational Site | Cheras | 56000 | Malaysia |
| Novo Nordisk Investigational Site | George Town | 10459 | Malaysia |
| Novo Nordisk Investigational Site | Kota Bharu, Kelantan | 16150 | Malaysia |
| Novo Nordisk Investigational Site | Kuala Lumpur | 59100 | Malaysia |
| Novo Nordisk Investigational Site | Putrajaya | 62250 | Malaysia |
| Novo Nordisk Investigational Site | Durango | Durango | 34000 | Mexico |
| Novo Nordisk Investigational Site | Mexico City | México, D.F. | 03300 | Mexico |
| Novo Nordisk Investigational Site | Monterrey | 64460 | Mexico |
| Novo Nordisk Investigational Site | Skopje | 1000 | North Macedonia |
| Novo Nordisk Investigational Site | Gjøvik | NO-2819 | Norway |
| Novo Nordisk Investigational Site | Hamar | 2317 | Norway |
| Novo Nordisk Investigational Site | Hønefoss | 3511 | Norway |
| Novo Nordisk Investigational Site | Oslo | 0586 | Norway |
| Novo Nordisk Investigational Site | Stavanger | 4005 | Norway |
| Novo Nordisk Investigational Site | Tønsberg | 3116 | Norway |
| Novo Nordisk Investigational Site | Kazan' | 420064 | Russia |
| Novo Nordisk Investigational Site | Moscow | 117036 | Russia |
| Novo Nordisk Investigational Site | Moscow | 119435 | Russia |
| Novo Nordisk Investigational Site | Moscow | 121356 | Russia |
| Novo Nordisk Investigational Site | Moscow | 127644 | Russia |
| Novo Nordisk Investigational Site | Saint Petersburg | 195257 | Russia |
| Novo Nordisk Investigational Site | Saint-Peterburg | 190068 | Russia |
| Novo Nordisk Investigational Site | Belgrade | 11000 | Serbia |
| Novo Nordisk Investigational Site | Johannesburg | Gauteng | 1829 | South Africa |
| Novo Nordisk Investigational Site | Johannesburg | Gauteng | 2001 | South Africa |
| Novo Nordisk Investigational Site | Durban | KwaZulu-Natal | 4126 | South Africa |
| Novo Nordisk Investigational Site | Taipei | 100 | Taiwan |
| Novo Nordisk Investigational Site | Taipei | 112 | Taiwan |
| Novo Nordisk Investigational Site | Taipei | 114 | Taiwan |
| Novo Nordisk Investigational Site | Taoyuan | 333 | Taiwan |
| Novo Nordisk Investigational Site | Belfast | BT16 1RH | United Kingdom |
| Novo Nordisk Investigational Site | Edgbaston, Birmingham | B15 2TH | United Kingdom |
| Novo Nordisk Investigational Site | Edinburgh | EH4 2XU | United Kingdom |
| Novo Nordisk Investigational Site | Glasgow | G45 9AW | United Kingdom |
| Novo Nordisk Investigational Site | Hull | HU3 2JZ | United Kingdom |
| Novo Nordisk Investigational Site | Ipswich | IP4 5PD | United Kingdom |
| Novo Nordisk Investigational Site | Londonderry | BT47 6SB | United Kingdom |
| Novo Nordisk Investigational Site | Swansea | SA6 6NL | United Kingdom |
| Sorli C, Warren M, Oyer D, Mersebach H, Johansen T, Gough SC. Elderly patients with diabetes experience a lower rate of nocturnal hypoglycaemia with insulin degludec than with insulin glargine: a meta-analysis of phase IIIa trials. Drugs Aging. 2013 Dec;30(12):1009-18. doi: 10.1007/s40266-013-0128-2. |
| 26121451 | Result | Einhorn D, Handelsman Y, Bode BW, Endahl LA, Mersebach H, King AB. PATIENTS ACHIEVING GOOD GLYCEMIC CONTROL (HBA1c <7%) EXPERIENCE A LOWER RATE OF HYPOGLYCEMIA WITH INSULIN DEGLUDEC THAN WITH INSULIN GLARGINE: A META-ANALYSIS OF PHASE 3A TRIALS. Endocr Pract. 2015 Aug;21(8):917-26. doi: 10.4158/EP14523.OR. Epub 2015 Jun 29. |
| 26232910 | Result | Russell-Jones D, Gall MA, Niemeyer M, Diamant M, Del Prato S. Insulin degludec results in lower rates of nocturnal hypoglycaemia and fasting plasma glucose vs. insulin glargine: A meta-analysis of seven clinical trials. Nutr Metab Cardiovasc Dis. 2015 Oct;25(10):898-905. doi: 10.1016/j.numecd.2015.06.005. Epub 2015 Jun 18. |
| 26663320 | Result | Vora J, Seufert J, Solberg H, Kinduryte O, Johansen T, Hollander P. Insulin degludec does not increase antibody formation versus insulin glargine: an evaluation of phase IIIa trials. Diabetes Obes Metab. 2016 Jul;18(7):716-20. doi: 10.1111/dom.12621. Epub 2016 Feb 8. |
| 23340894 | Derived | Meneghini L, Atkin SL, Gough SC, Raz I, Blonde L, Shestakova M, Bain S, Johansen T, Begtrup K, Birkeland KI; NN1250-3668 (BEGIN FLEX) Trial Investigators. The efficacy and safety of insulin degludec given in variable once-daily dosing intervals compared with insulin glargine and insulin degludec dosed at the same time daily: a 26-week, randomized, open-label, parallel-group, treat-to-target trial in individuals with type 2 diabetes. Diabetes Care. 2013 Apr;36(4):858-64. doi: 10.2337/dc12-1668. Epub 2013 Jan 22. |
Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks. |
| FG002 | IGlar OD | Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks. |
| Exposed |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IDeg OD FF | Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses). |
| BG001 | IDeg OD | Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks. |
| BG002 | IGlar OD | Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||
| Glycosylated haemoglobin (HbA1c) | Mean | Standard Deviation | percentage of glycosylated haemoglobin |
| |||||||||||||||
| Fasting plasma glucose (FPG) | Mean | Standard Deviation | mmol/L |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Glycosylated Haemoglobin (HbA1c) | Change from baseline in HbA1c after 26 weeks of treatment | The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF). In FAS, subjects contributed to the evaluation 'as randomised'. | Posted | Mean | Standard Deviation | percentage of glycosylated haemoglobin | Week 0, Week 26 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) | Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, before bedtime, at 4 am and before breakfast. | The FAS included all randomised subjects and missing data is imputed using last observation carried forward (LOCF). In FAS, subjects contributed to the evaluation 'as randomised'. For 28 subjects all 9-point SMPG values were missing. | Posted | Mean | Standard Deviation | mmol/L | Week 26 |
| |||||||||||||||||||||||||||||||||
| Secondary | Rate of Confirmed Hypoglycaemic Episodes | Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. | The SAS included all subjects who received at least one dose of the investigational product or its comparator. In SAS, subjects contributed to the evaluation 'as treated'.230 subjects in the IDeg Flex group, 226 in the IDeg OD group and 229 in the IGlar OD group | Posted | Number | Episodes/100 years of patient exposure | Week 0 to Week 26 + 7 days follow up |
| ||||||||||||||||||||||||||||||||||
| Secondary | Rate of Nocturnal Confirmed Hypoglycaemic Episodes | Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m. | The SAS included all subjects who received at least one dose of the investigational product or its comparator. In SAS, subjects contributed to the evaluation 'as treated'.230 subjects in the IDeg Flex group, 226 in the IDeg OD group and 229 in the IGlar OD group | Posted | Number | Episodes/100 years of patient exposure | Week 0 to Week 26 + 7 days follow up |
|
The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IDeg OD FF | Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses). | 6 | 230 | 58 | 230 | ||
| EG001 | IDeg OD | Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks. | 8 | 226 | 57 | 226 | ||
| EG002 | IGlar OD | Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks. | 4 | 229 | 53 | 229 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypoglycaemic unconsciousness | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Oral neoplasm benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Transurethral prostatectomy | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
Novo Nordisk maintains the right to be informed of any Investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571886 | insulin degludec |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
|
|
|
Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks. |
|
|
| OG002 |
| IGlar OD |
Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks. |
|
|