By: Ed Susman

SAN DIEGO, CA – A multidisciplinary, clinical, team-led intensive, lifestyle-intervention program among patients with type 2 diabetes appears to maintain the benefits seen in 12 weeks for at least as long as 3 years, researchers stated at the American Diabetes Association 71st Scientific Sessions.

Patients who had a mean glycosylated haemoglobin A1C (Hb A1C) of 7.6% at baseline were able to lower the Hb A1C to 6.6% after 12 weeks (P <.001) of the intensive program and were still at 7% after 3 years, also a significant reduction from baseline (P <.01).

“Lifestyle intervention can be accomplished in clinical practice,” said Osama Hamdy, MD, Joslin Clinic, and Harvard Medical School, Boston, Massachusetts.

Dr. Hamdy said the Weight Achievement and Intensive Treatment program (WAIT) has been incorporated into regular practice at the Joslin Clinic.

The researchers enrolled 141 patients with diabetes -- 127 with type 2 diabetes and 14 patients with type 1 diabetes. The patients had a mean age of 53.3 years and had been diagnosed with diabetes for about 9.5 years. Ninety-one of the patients were women. The average weight of the participants was 108.86 kg (240 lbs).

Six of the patients dropped out of the study before completing 12 weeks, Dr. Hamdy noted. He reported on 135 patients who completed 2 years of follow-up (105 had completed 2.5 years and 70 patients had completed 3 years of follow-up).

The interdisciplinary team included a diabetologist, a registered dietician, a clinical exercise physiologist, and a psychologist. Changes in medication were made with special emphasis on weight-neutral or weight-negative medications.

The dietary intervention gave patients a choice of 15 dinner meals, 2 meal replacements, and snacks designed to meet the Joslin Clinics nutritional guidelines for diabetics — a diet plan that included 40% to 45% carbohydrates, 20% to 30% protein, and <35% fat. “The menus were designed by a registered dietician to be low in glycaemic index, high in fiber, and low in saturated fat,” Dr. Hamdy explained.

The researchers also put the patients through a structured strength and cardiovascular exercise program that gradually increased activity. For the first 4 sessions, patients were encouraged to exercise 20 to 40 minutes 4 days a week; during the next 4 sessions, the exercise prescription was increased to 40 to 45 minutes 5 days a week; and in the final 4 sessions, patients were told to exercise 50 to 60 minutes 6 days a week.

The patients also attended weekly teaching and behavioural support sessions. At the end of the program, participants were instructed to follow the same plan on their own.

The average weight loss after 12 weeks of the study was 10.9 kg (24.1 lbs). Weight loss averaged 8.26 kg (18.2 lbs) at 1 year; 8.53 kg (18.8 lbs) at 2 years; and 7.8 kg (17.2 lbs) at 2.5 and 3 years.

The patient change in Hb A1C decreased from 7.6% to 6.6% after 12 weeks; was 7% after 1 year; was 6.9% at 2 years; 7% at 2.5 years; and 7% at 3 years. Approximately 82% of patients achieved the goal of 7% after 12 weeks, but that percentage declined to 47% of patients at 2 years, 43% of patients at 2.5 years, and 40% of patients at 3 years.

- MFP Wire Services
- 06-29-2011

By: Ed Susman

SAN DIEGO, CA – Treatment of diabetes varies greatly in clinical practice worldwide – but there is one constant, researchers said: Doctors tend to delay treatment with insulin in every region of the globe.

“We were surprised to find that while doctors in the South Asia region will prescribe insulin to their patients after an average of 6.4 years after diagnosis, doctors in Latin America tend to wait 12 years after diagnosis to begin treatment with insulin,” said Pradana Soewondo, MD, professor of medicine at the University of Indonesia, Jakarta.

Overall, the researchers reported that, worldwide, the mean time to beginning treatment with insulin for patients diagnosed with type 2 diabetes was about eight years, Soewondo said at his poster presentation during the annual meeting of the American Diabetes Association.

He reported preliminary data from the ongoing A1chieve trial sponsored by Novo Nordisk. The 24-week, open-label, multinational, observational study is evaluating the safety and clinical effectiveness of insulin detemir, insulin aspart, and biphasic insulin aspart in people with type 2 diabetes in routine clinical practice.

The researchers enrolled 66,726 patients from 28 countries across Asia, Africa, Europe and Latin America into the study. The patients’ baseline characteristics indicated that mean glycosylated hemoglobin A1c (HbA1c) between regions was 9.4% to 10.0% across treatment groups.

In spite of this poor glycemic control, Soewondo and colleagues found that 11% of participants had been on no medication for an average duration of 4.6 years of diabetes, with marked variability by region, from 2.2 years in South Asia to more than eight years in the Middle East/Gulf and Latin America.

Duration of diabetes when beginning insulin in patients using oral glucose-lowering drugs also varied markedly between regions, from 6.2 to 13.8 years, and more than 77% of oral glucose-lowering drug-only patients were taking two or more such agents. “Baseline glycemic control in people starting insulin analogs was poor across all regions, with factors suggesting high variability of practice but always reflecting a delay in beginning or optimizing insulin therapy,” Soewondo said.

Across the study, about 55% of the participants were men; the average age of the participants was 54.2 years.

“What we are seeing with this study is that clinical inertia in when to start insulin therapy is a global phenomenon,” said David Kendall, MD, chief scientific and medical officer of the American Diabetes Association.

“The easiest thing to do in medicine is to do nothing,” Kendall said. “The best treatment plan for our patients is to control glucose for as long as possible as soon as possible and as safely as possible.”

In the study, the average time to treatment with insulin:

* Among the 11,020 patients in China was 6.3 years.
* Among the 22,447 patients in South Asia was 6.4 years.
* Among the 10,032 patients in East Asia was 8.6 years.
* Among the 4,039 patients in North Africa was 11.5 years.
* Among the 14,976 patients in the Middle East was 9.8 years.
* Among the 1,138 patients in Latin America was 12 years.
* Among the 3,074 patients in Russia was 8.4 years.

“These results suggest that while management of type 2 diabetes varies across different countries and regions, a common factor is a delay in starting and/or optimizing insulin therapy,” Soewondo said.

- MFP Wire Services
- 06-28-2011

By: Ed Susman

SAN DIEGO, CA – Patients with diabetes who are treated with the glucagon-like peptide-1 agonist liraglutide early in the disease seem to get more clinical benefit with the new agent than patients who receive the drug later in their disease stage, researchers said at the American Diabetes Association 71st Scientific Sessions.

“However, even treating patients late in their disease with high-dose liraglutide resulted in substantial decrease of Hb A1C [glycated haemoglobin],” added David Matthews, MBBS, Oxford University, England. “So we can say that even treating later in the disease is not futile.”

Dr. Matthews reported in his poster presentation that Hb A1C was decreased 1.55 percentage points among patients who were either naïve to oral antidiabetes therapy or were on 1 oral drug compared with a decline of 1.18 percentage points among those patients on 2 or more oral drugs (P <.0001).

Dr. Matthews and colleagues reviewed data from a series of clinical trials. They identified 492 patients treated early with 1.8 mg liraglutide; 432 patients treated early with liraglutide 1.2 mg daily; 355 patients treated late with liraglutide 1.8 mg daily; and 28 patients treated late with 1.2 mg daily of liraglutide.

For the analysis, patients who participated in the randomised phase 3 clinical trials were stratified according to previous treatment status: diet/exercise or 1 oral antidiabetic medication, which was defined as “early treatment,” versus 2 oral antidiabetic drugs, which was defined as “late treatment.”

The patients who were in the early-treatment stratification had been diagnosed with diabetes for about 6 years while those treated late had been living with diabetes for more than 9 years.

Dr. Matthews noted that 72% of patients achieved the ADA Hb A1C target of less than 7% with liraglutide 1.8 mg given early compared with 49% of patients who were treated with the drug late in the course of their disease (P <.0001).

He also reported that 61% of the patients treated early with liraglutide 1.2 mg daily achieved the ADA goal compared with 49% of those treated late with liraglutide 1.2 mg daily, although that difference did not reach statistical significance (P =.1526).

Patients treated early with the 1.2-mg daily dose of liraglutide achieved an Hb A1C reduction of 1.38 compared with an Hb A1C reduction of 0.82 among those patients treated with 1.2 mg daily of liraglutide late in their treatment (P =.0027).

“These data suggest that the use of liraglutide early in the disease may provide better overall clinical benefits and improvement in beta-cell function,” Dr. Matthews concluded.

- MFP Wire Services
- 06-28-2011