Observational Study on the Effect of NovoMix® 30, Levemir® or NovoRapid® (Alone or Combined) in Type 2 Diabetics Previously Treated With Anti-diabetic Medication

NCT00869908 | Completed

• 1 other identifier: INS-3693
• Study Type: observational
• Target: 66,726
• Locations: 21 countries
• Sites: 21

Brief Summary

This study is conducted in Africa, Asia, South America and Europe. The aim of this observational study is to document the experience with the study insulins when used in routine clinical practice. After the physician's decision to start insulin treatment using NovoMix® 30, Levemir® or NovoRapid® (alone or combined), type 2 diabetics will be eligible to be included in this study at the physician's discretion

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Number of serious adverse drug reactions and major hypoglycaemic events reported as serious adverse drug reactions

  at baseline, 12 weeks and 24 weeks

Secondary Outcomes (5)

• Evaluate the prescribing patterns and choice of insulin analogues in routine clinical practice

  at baseline, 12 weeks and 24 weeks

• Change in number of hypoglycaemic events

  at baseline, 12 weeks and 24 weeks

• Change in HbA1c

  at baseline, 12 weeks and 24 weeks

• Change in FPG (Fasting Plasma Glucose)

  at baseline, 12 weeks and 24 weeks

• Change in PPG (postprandial glucose)

  at baseline, 12 weeks and 24 weeks

Study Arms (1)

A

Drug: insulin aspart; Drug: insulin detemir; Drug: biphasic insulin aspart

Interventions

insulin aspart DRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Also known as: NovoRapid®, ANA

A

insulin detemir DRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

A

biphasic insulin aspart DRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Only people with type 2 diabetes treated by general practitioners and specialists who prescribe insulin analogues in their routine practice will be included

You may qualify if:

• The selection of the subjects will be at the discretion of the individual physician.

You may not qualify if:

• Subjects who were previously enrolled in this study.
• Subjects with a hypersensitivity to NovoMix® 30, Levemir® or NovoRapid® or to any of the excipients.
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (22)

Novo Nordisk Investigational Site

Algiers, 16035, Algeria

Location

Novo Nordisk Investigational Site

Prov. de Buenos Aires, B1636DSU, Argentina

Location

Novo Nordisk Investigational Site

Dhaka, 1206, Bangladesh

Location

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, 100004, China

Location

Novo Nordisk Investigational Site

Cairo, Egypt

Location

Novo Nordisk Investigational Site

Bangalore, 560001, India

Location

Novo Nordisk Investigational Site

Jakarta, 12520, Indonesia

Location

Novo Nordisk Investigational Site

Tehran, Iran

Location

Novo Nordisk Investigational Site

Amman, 11844, Jordan

Location

Novo Nordisk Investigational Site

Tripoli, Libya

Location

Novo Nordisk Investigational Site

Selangor Darul Ehsan, Malaysia

Location

Novo Nordisk Investigational Site

Mexico City, Mexico

Location

Novo Nordisk Investigational Site

Casablanca, 20000, Morocco

Location

Novo Nordisk Investigational Site

Karachi, Pakistan

Location

Novo Nordisk Investigational Site

Manila, 1605, Philippines

Location

Novo Nordisk Investigational Site

Moscow, 119330, Russia

Location

Novo Nordisk Investigational Site

Riyadh, 3542, Saudi Arabia

Location

Novo Nordisk Investigational Site

Singapore, 307684, Singapore

Location

Novo Nordisk Investigational Site

Seoul, 137-920, South Korea

Location

Novo Nordisk Investigational Site

Taipei, Taiwan

Location

Novo Nordisk Investigational Site

Tunisia, 1053, Tunisia

Location

Novo Nordisk Investigational Site

Istanbul, 34335, Turkey (Türkiye)

Location

Related Publications (17)

• Home P, Naggar NE, Khamseh M, Gonzalez-Galvez G, Shen C, Chakkarwar P, Wenying Y. An observational non-interventional study of people with diabetes beginning or changed to insulin analogue therapy in non-Western countries: the A1chieve study. Diabetes Res Clin Pract. 2011 Dec;94(3):352-63. doi: 10.1016/j.diabres.2011.10.021.

  PMID: 22153567 RESULT

• Shah S, Zilov A, Malek R, Soewondo P, Bech O, Litwak L. Improvements in quality of life associated with insulin analogue therapies in people with type 2 diabetes: results from the A1chieve observational study. Diabetes Res Clin Pract. 2011 Dec;94(3):364-70. doi: 10.1016/j.diabres.2011.10.020.

  PMID: 22153568 RESULT

• Shah SN, Litwak L, Haddad J, Chakkarwar PN, Hajjaji I. The A1chieve study: a 60 000-person, global, prospective, observational study of basal, meal-time, and biphasic insulin analogs in daily clinical practice. Diabetes Res Clin Pract. 2010 May;88 Suppl 1:S11-6. doi: 10.1016/S0168-8227(10)70003-6.

  PMID: 20466163 RESULT

• Randeree H, Liebl A, Hajjaji I, Khamseh M, Zajdenverg L, Chen JW, Haddad J. Safety and effectiveness of bolus insulin aspart in people with type 2 diabetes: a1chieve sub-analysis. Diabetes Ther. 2013 Jun;4(1):153-66. doi: 10.1007/s13300-013-0026-y. Epub 2013 Jun 12.

  PMID: 23757032 RESULT

• Zilov A, El Naggar N, Shah S, Shen C, Haddad J. Insulin detemir in the management of type 2 diabetes in non-Western countries: safety and effectiveness data from the A(1)chieve observational study. Diabetes Res Clin Pract. 2013 Sep;101(3):317-25. doi: 10.1016/j.diabres.2013.06.003.

  PMID: 24119589 RESULT

• Shah S, Yang W, Hasan MI, Malek R, Molskov Bech O, Home P. Biphasic insulin aspart 30 in insulin-naive people with type 2 diabetes in non-western nations: results from a regional comparative multinational observational study (A(1)chieve). Diabetes Technol Ther. 2013 Nov;15(11):954-63. doi: 10.1089/dia.2013.0074. Epub 2013 Sep 20.

  PMID: 24053450 RESULT

• Home PD, Latif ZA, Gonzalez-Galvez G, Prusty V, Hussein Z. The effectiveness and safety of beginning insulin aspart together with basal insulin in people with type 2 diabetes in non-Western nations: results from the A(1)chieve observational study. Diabetes Res Clin Pract. 2013 Sep;101(3):326-32. doi: 10.1016/j.diabres.2013.06.005.

  PMID: 24119590 RESULT

• Litwak L, Goh SY, Hussein Z, Malek R, Prusty V, Khamseh ME. Prevalence of diabetes complications in people with type 2 diabetes mellitus and its association with baseline characteristics in the multinational A1chieve study. Diabetol Metab Syndr. 2013 Oct 24;5(1):57. doi: 10.1186/1758-5996-5-57.

  PMID: 24228724 RESULT

• Chen L, Xing X, Lei M, Liu J, Shi Y, Li P, Qin G, Li C, Li Y, Wang Q, Gao T, Hu L, Wang Y, Yang W. Biphasic insulin aspart 30 improved glycemic control in Chinese patients with type 2 diabetes poorly controlled on oral glucose-lowering drugs: a subgroup analysis of the A(1)chieve study. Chin Med J (Engl). 2014;127(2):208-12.

  PMID: 24438605 RESULT

• Hwang YC, Kang JG, Ahn KJ, Cha BS, Ihm SH, Lee S, Kim M, Lee BW. The glycemic efficacies of insulin analogue regimens according to baseline glycemic status in Korean patients with type 2 diabetes: sub-analysis from the A(1)chieve((R)) study. Int J Clin Pract. 2014 Nov;68(11):1338-44. doi: 10.1111/ijcp.12482. Epub 2014 Oct 6.

  PMID: 25284679 RESULT

• Yang W, Zhuang X, Li Y, Wang Q, Bian R, Shen J, Hammerby E, Yang L. Improvements in quality of life associated with biphasic insulin aspart 30 in type 2 diabetes patients in China: results from the A1chieve(R) observational study. Health Qual Life Outcomes. 2014 Nov 26;12:137. doi: 10.1186/s12955-014-0137-9.

  PMID: 25424627 RESULT

• Khamseh ME, Haddad J, Yang W, Zilov A, Bech OM, Hasan MI. Safety and effectiveness of biphasic insulin aspart 30 in different age-groups: a1chieve sub-analysis. Diabetes Ther. 2013 Dec;4(2):347-61. doi: 10.1007/s13300-013-0033-z. Epub 2013 Jul 17.

  PMID: 23860823 RESULT

• Home PD, Shen C, Hasan MI, Latif ZA, Chen JW, Gonzalez Galvez G. Predictive and explanatory factors of change in HbA1c in a 24-week observational study of 66,726 people with type 2 diabetes starting insulin analogs. Diabetes Care. 2014;37(5):1237-45. doi: 10.2337/dc13-2413. Epub 2014 Mar 4.

  PMID: 24595628 RESULT

• El-Naggar N, Almansari A, Khudada K, Salman S, Mariswamy N, Abdelfattah W, Hashim F. The A1 chieve study - an observational non-interventional study of patients with type 2 diabetes mellitus initiating or switched to insulin analogue therapy: subgroup analysis of the Gulf population. Int J Clin Pract. 2013 Feb;67(2):128-38. doi: 10.1111/ijcp.12078.

  PMID: 23305475 RESULT

• El Naggar NK, Soewondo P, Khamseh ME, Chen JW, Haddad J. Switching from biphasic human insulin 30 to biphasic insulin aspart 30 in type 2 diabetes is associated with improved glycaemic control and a positive safety profile: results from the A(1)chieve study. Diabetes Res Clin Pract. 2012 Dec;98(3):408-13. doi: 10.1016/j.diabres.2012.09.043.

  PMID: 23217267 RESULT

• Song SO, Hwang YC, Ahn KJ, Cha BS, Song YD, Lee DW, Lee BW. Clinical Characteristics of Patients Responding to Once-Daily Basal Insulin Therapy in Korean Subjects with Type 2 Diabetes. Diabetes Ther. 2015 Dec;6(4):547-558. doi: 10.1007/s13300-015-0140-0. Epub 2015 Oct 29.

  PMID: 26515457 DERIVED

• Gupta V, Baabbad R, Hammerby E, Nikolajsen A, Shafie AA. An analysis of the cost-effectiveness of switching from biphasic human insulin 30, insulin glargine, or neutral protamine Hagedorn to biphasic insulin aspart 30 in people with type 2 diabetes. J Med Econ. 2015 Apr;18(4):263-72. doi: 10.3111/13696998.2014.991791. Epub 2015 Jan 2.

  PMID: 25426701 DERIVED

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Insulin Aspart; Insulin Detemir; insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: March 26, 2009
• Study Start: November 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: January 19, 2017

Record last verified: 2017-01

Locations

LI (1); TW (1); SG (1); RU (1); PA (1); MY (1); PH (1); TU (1); EG (1); BA (1); CN (1); IN (1); SA (1); KR (1); ME (1); AL (1); ID (1); IR (1); AR (1); MO (1); JO (1)